Data / Medical devices / United States / Arrow International, LLC (subsidiary of Teleflex Incorporated)
Arrow International, LLC (subsidiary of Teleflex Incorporated): FDA-registered device maker in Wyomissing, PA, United States, 138 510(k) clearances
Arrow International, LLC (subsidiary of Teleflex Incorporated) is registered with the FDA (registration 3015859709) in Wyomissing, PA, United States. It lists 49 device types. The FDA files 138 510(k) clearances under its listings, the newest dated March 14, 2025. 116 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015859709
- Address
- 35 Innovation Way, Wyomissing, PA, United States, 19610
- Owner or operator
- Arrow International LLC (subsidiary of Teleflex Incorporated (2518433)
- Roles
- Specification developer
- First device listed
- February 2, 1995
- Registered through
- 2026
- Brand names listed
- - Arrow PICC Powered by Arrow VPS Stylet, 14 Fr 2-L Hemodialysis Catheters, 2 LUMEN/PSI KIT, 2- Lumen PICC Products w/ Blue Flex, 2-L MAC KIT, 2-Lumen Central Venous Access (MAC), AC3 Optimus, AC3 Series IABP System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 138.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 14, 2025 | K243599 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | FOZ | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| December 20, 2024 | K242281 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) | FOZ | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| February 13, 2023 | K222341 | Arrow 0.2 Micron Flat Filter, GVS | CAZ | Substantially Equivalent | Arrow International, LLC | accessdata.fda.gov |
| September 2, 2022 | K213855 | Arrow Pressure Injectable Midline Catheter | PND | Substantially Equivalent | Arrow International, LLC Subsidiary of Teleflex Incorporated | accessdata.fda.gov |
| August 30, 2022 | K220280 | Arrow Stiffening Stylet | DRB | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| August 22, 2022 | K220363 | VPS Rhythm DLX Device with TipTracker Technology | LJS | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| November 9, 2018 | K180395 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| April 25, 2018 | K173321 | StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1) Peripheral Nerve Block Needle | BSP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| April 17, 2018 | K180588 | FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device | FMI | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| June 23, 2017 | K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | DQY | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | accessdata.fda.gov |
| March 31, 2017 | K162820 | AC3 Series IABP System | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| March 17, 2017 | K162522 | UltraCath Continuous Nerve block Catheter | BSO | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 24, 2017 | K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| December 22, 2016 | K160925 | VPS Rhythm Device with TipTracker Technology | LJS | Substantially Equivalent | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| October 4, 2016 | K161075 | Arrow Epidural Catheter Kit | CAZ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| August 24, 2016 | K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | PND | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| June 21, 2016 | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| July 24, 2015 | K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | NIE | Unknown | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| July 8, 2015 | K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | Substantially Equivalent | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| March 27, 2015 | K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | BSO | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| January 27, 2015 | K142889 | Celerity PICC Tip Confirmation System | LJS | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 8, 2014 | K141618 | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS | OBJ | Substantially Equivalent | Arrow International, Inc (Subsidiary of Teleflex I | accessdata.fda.gov |
| July 8, 2014 | K141117 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | Vidacare, LLC | accessdata.fda.gov |
| July 7, 2014 | K141051 | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU | MSD | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 13, 2014 | K140799 | CELERITY SYSYEM | LJS | Substantially Equivalent | Medcomp (Medical Components, Inc.) | accessdata.fda.gov |
| February 11, 2014 | K132583 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| September 26, 2013 | K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET | OBJ | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| May 10, 2013 | K130192 | NEXTSTEP RETROGRADE | MSD | Unknown | Arrow International, Inc. | accessdata.fda.gov |
| April 26, 2013 | K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| January 18, 2013 | K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | OBJ | Substantially Equivalent | Vasonova, Inc. | accessdata.fda.gov |
| January 4, 2013 | K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | DYB | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| December 21, 2012 | K122690 | ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| November 29, 2012 | K121501 | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| September 20, 2012 | K122545 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| September 7, 2012 | K121941 | ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| August 28, 2012 | K122027 | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 21, 2012 | K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 20, 2012 | K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| June 3, 2012 | K120661 | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| May 16, 2012 | K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| May 10, 2012 | K112896 | ARRW EVOLUTION | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| August 17, 2011 | K111900 | NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER | MSD | Unknown | Teleflexmedical, Inc. | accessdata.fda.gov |
| June 30, 2011 | K111117 | CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... | MSD | Unknown | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 18, 2011 | K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | OBJ | Substantially Equivalent | Vasonova, Inc. | accessdata.fda.gov |
| February 18, 2011 | K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | OBJ | Substantially Equivalent | Vasonova, Inc. | accessdata.fda.gov |
| February 1, 2011 | K102238 | ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| August 27, 2010 | K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | LJS | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| July 27, 2010 | K101026 | POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| December 18, 2009 | K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 14, 2009 | K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| January 15, 2008 | K073451 | PRESSURE INJECTABLE PICC | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| October 10, 2007 | K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | KKX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| September 26, 2007 | K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | FMI | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 30, 2007 | K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| July 17, 2007 | K071111 | NON-ABSORBABLE SILK SUTURE | GAP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 26, 2007 | K063567 | EZ-MIO STERNAL | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| December 8, 2006 | K063142 | MANUAL PD-IO; POWERED PD-IO | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| December 5, 2006 | K062956 | EZ-MIO, EZ-IO DISTAL TIBIA | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| November 7, 2006 | K062422 | HUMERAL HEAD, MANUAL DRIVER | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| August 24, 2006 | K061289 | ARROW PRESSURE INJECTABLE PICC | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| November 17, 2005 | K052408 | EZ-IO | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| November 2, 2005 | K052195 | EZ-MIO MANUAL DRIVER | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| October 20, 2005 | K051992 | POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| February 18, 2005 | K043490 | PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| July 12, 2004 | K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | FMI | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 14, 2004 | K040666 | STEP-TIP CHRONIC HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| March 10, 2004 | K032885 | VIDAPORT INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| March 5, 2004 | K040260 | INTEGRAL HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Arrow Int'L. | accessdata.fda.gov |
| March 1, 2004 | K040100 | ARROW ECHOGENIC INTRODUCER NEEDLE | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 13, 2004 | K040078 | CANNON II PLUS | MSD | Unknown | Arrow International, Inc. | accessdata.fda.gov |
| May 9, 2003 | K022662 | DIATEK CANNON-CATHETER, MODEL CC5500 | MSD | Unknown | Arrow Intl., Inc. | accessdata.fda.gov |
| April 23, 2003 | K030937 | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| August 8, 2002 | K021723 | SHEATH ADAPTER, MODEL SA-09847 | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| July 16, 2002 | K014246 | AVID-NIT NERVE STIMULATION NEEDLES | CAZ | Substantially Equivalent | Avid N.I.T., Inc. | accessdata.fda.gov |
| June 19, 2002 | K021567 | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 9, 2002 | K020430 | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) | NFK | Substantially Equivalent | Diatek, Inc. | accessdata.fda.gov |
| May 2, 2002 | K021120 | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 31, 2001 | K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 14, 2001 | K010399 | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) | MSD | Substantially Equivalent | Diatek, Inc. | accessdata.fda.gov |
| March 21, 2001 | K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 27, 2000 | K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION | LJT | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| September 14, 2000 | K993933 | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO | MPB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 29, 2000 | K001731 | AVID-NIT LOSS OF RESISTANCE SYRINGE | FMF | Substantially Equivalent | Avid Medical, Inc. | accessdata.fda.gov |
| March 24, 2000 | K993191 | TFX MEDICAL INTRODUCER ASSEMBLY | DYB | Substantially Equivalent | Tfx Medical, Inc. | accessdata.fda.gov |
| March 8, 2000 | K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 26, 1999 | K991431 | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT | MPB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 18, 1999 | K984022 | PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT | MPB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 13, 1998 | K970229 | ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 17, 1997 | K970864 | ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS | FOZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 21, 1997 | K962577 | ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 4, 1997 | K963257 | PERIPHERALLY INSERTED MEDLINE CATHETER | LJS | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 25, 1997 | K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| October 17, 1996 | K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER | LDF | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 26, 1996 | K953746 | ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET | FPA | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 8, 1995 | K945229 | ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS | DRF | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| November 30, 1994 | K940079 | ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| March 28, 1994 | K930129 | ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | Unknown | Arrow Intl., Inc. | accessdata.fda.gov |
| August 15, 1993 | K924385 | NEW HYDROPHILIC COATING FOR WIRE GUIDES | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 13, 1993 | K923653 | NEEDLELESS INJECTION CANNULA | LJS | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 116.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 20, 2021 | 88796 | Class I | Terminated | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive U | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. | accessdata.fda.gov |
| May 19, 2021 | 88120 | Class II | Ongoing | Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording. | Marketed without a 510K | accessdata.fda.gov |
| March 8, 2021 | 87499 | Class II | Ongoing | Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of | Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure | accessdata.fda.gov |
| January 6, 2021 | 87092 | Class II | Terminated | Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A | The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in | accessdata.fda.gov |
| July 6, 2020 | 86044 | Class II | Terminated | Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space. | The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date. | accessdata.fda.gov |
| May 20, 2020 | 85684 | Class I | Terminated | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the | accessdata.fda.gov |
| May 8, 2020 | 85645 | Class II | Ongoing | Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-0 | Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. | accessdata.fda.gov |
| January 15, 2020 | 84726 | Class II | Terminated | FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. | accessdata.fda.gov |
| December 20, 2019 | 84688 | Class II | Terminated | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 | Product lidstock contains the incorrect expiration date for the product | accessdata.fda.gov |
| December 12, 2019 | 84635 | Class II | Ongoing | Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral.018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterizatio | The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit | accessdata.fda.gov |
| December 6, 2019 | 84520 | Class II | Terminated | Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH | Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. | accessdata.fda.gov |
| November 15, 2019 | 84399 | Class II | Terminated | Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 | Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result | accessdata.fda.gov |
| August 6, 2019 | 83593 | Class II | Terminated | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access | Products may contain the incorrect banner card within the kit | accessdata.fda.gov |
| July 18, 2019 | 83456 | Class II | Terminated | Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits | Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length | accessdata.fda.gov |
| May 17, 2019 | 82984 | Class II | Terminated | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner. | accessdata.fda.gov |
| April 23, 2019 | 82865 | Class II | Terminated | Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA | Lidstock states the incorrect expiration date for the product | accessdata.fda.gov |
| January 10, 2019 | 82070 | Class II | Terminated | Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132 | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct | accessdata.fda.gov |
| December 13, 2018 | 82506 | Class II | Terminated | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for in | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC | accessdata.fda.gov |
| November 14, 2018 | 81665 | Class II | Terminated | Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access | The lidstock states the incorrect priming volume and flow rates. | accessdata.fda.gov |
| October 2, 2018 | 81375 | Class II | Terminated | AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescr | accessdata.fda.gov |
| September 21, 2018 | 81242 | Class II | Terminated | Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length,.025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulat | The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is.032 rather than the correct SWG size.025. For other lots in scope the lidstock correctly states the SWG size.025 however the banner card states the incorrect SWG size.032. | accessdata.fda.gov |
| August 30, 2018 | 81117 | Class II | Terminated | Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous | The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifies an incorrect expiration date. Per standard clinical practice the lidstock would most likely be checked prior to use and the product would not be used leading | accessdata.fda.gov |
| July 30, 2018 | 80872 | Class II | Terminated | ARROW Bipolar Electrode Catheter with shrouded pins, 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac sti | Products are labeled with an incorrect expiration date | accessdata.fda.gov |
| July 17, 2018 | 80839 | Class II | Terminated | 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2 | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained. | accessdata.fda.gov |
| July 10, 2018 | 80682 | Class II | Terminated | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. | accessdata.fda.gov |
| July 3, 2018 | 80631 | Class II | Terminated | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatri | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue. | accessdata.fda.gov |
| May 23, 2018 | 80378 | Class II | Terminated | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length.035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter intro | Product contains dry natural rubber latex. Label states Latex Free. | accessdata.fda.gov |
| May 17, 2018 | 80299 | Class II | Terminated | VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip app | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. | accessdata.fda.gov |
| May 11, 2018 | 80227 | Class II | Terminated | Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jug | The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter. | accessdata.fda.gov |
| April 11, 2018 | 79890 | Class II | Terminated | Catheter Hemostasis Valve For use with.038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000 | Product sterility may be compromised due to unsealed packaging. | accessdata.fda.gov |
| December 22, 2017 | 79512 | Class II | Terminated | (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | accessdata.fda.gov |
| December 21, 2017 | 79528 | Class II | Terminated | ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard t | Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information. | accessdata.fda.gov |
| December 15, 2017 | 79474 | Class II | Terminated | ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B | Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries. | accessdata.fda.gov |
| November 27, 2017 | 79339 | Class II | Terminated | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of d | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. | accessdata.fda.gov |
| November 14, 2017 | 79342 | Class II | Terminated | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to t | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. | accessdata.fda.gov |
| October 26, 2017 | 79314 | Class II | Terminated | Radial Artery Catheterization Kit; Model: AK-04018 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | accessdata.fda.gov |
| October 24, 2017 | 79294 | Class II | Terminated | Large Volume Abdominal Paracentesis Kit | Product packaging may not be completely sealed. | accessdata.fda.gov |
| October 17, 2017 | 79200 | Class II | Terminated | ARROW PICC powered by ARROW VPS Stylet | The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter. | accessdata.fda.gov |
| October 17, 2017 | 79197 | Class II | Terminated | Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018 | These finished good kits may contain the incorrect Springwire Guide (SWG). | accessdata.fda.gov |
| July 25, 2017 | 78964 | Class II | Terminated | ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained. | accessdata.fda.gov |
| July 10, 2017 | 78681 | Class II | Terminated | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels. | Needle supplier indicated the presence of loose polypropylene foreign matter above release specification. | accessdata.fda.gov |
| June 12, 2017 | 77604 | Class II | Terminated | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. | accessdata.fda.gov |
| June 1, 2017 | 77589 | Class II | Terminated | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally ins | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. | accessdata.fda.gov |
| May 9, 2017 | 77232 | Class II | Terminated | Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. | accessdata.fda.gov |
| April 28, 2017 | 77163 | Class II | Terminated | Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters | Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing. | accessdata.fda.gov |
| March 20, 2017 | 76937 | Class II | Terminated | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lu | Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products. | accessdata.fda.gov |
| March 17, 2017 | 76935 | Class II | Terminated | Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended | Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover. | accessdata.fda.gov |
| March 3, 2017 | 76637 | Class II | Terminated | The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein. | Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC- | accessdata.fda.gov |
| January 11, 2017 | 76237 | Class II | Terminated | Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. | There have been complaints for peel away sheaths flaring | accessdata.fda.gov |
| September 2, 2016 | 75372 | Class II | Terminated | HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practition | Labeling inconsistency | accessdata.fda.gov |
| August 8, 2016 | 74986 | Class II | Terminated | Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels. | Shipping carton labeling error. | accessdata.fda.gov |
| July 7, 2016 | 75014 | Class II | Terminated | Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli. | Arrow is recalling due to incorrect labeling of products. | accessdata.fda.gov |
| June 2, 2016 | 74489 | Class II | Terminated | Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access t | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits. | accessdata.fda.gov |
| June 2, 2016 | 74362 | Class II | Terminated | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring ce | Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit. | accessdata.fda.gov |
| February 17, 2016 | 74898 | Class II | Terminated | Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components | Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. | accessdata.fda.gov |
| January 12, 2016 | 73045 | Class II | Terminated | Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker | Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur. | accessdata.fda.gov |
| October 16, 2015 | 72463 | Class II | Terminated | ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet ARROW Pressure Injectable JACC wi | Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter. | accessdata.fda.gov |
| September 18, 2015 | 72244 | Class II | Terminated | 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days. | Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections. | accessdata.fda.gov |
| August 27, 2015 | 72086 | Class II | Terminated | Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products. | accessdata.fda.gov |
| July 30, 2015 | 71855 | Class II | Terminated | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported. | accessdata.fda.gov |
| July 30, 2015 | 71854 | Class II | Terminated | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound | the catheter peel-away component hub tabs may prematurely detach. One injury reported. | accessdata.fda.gov |
| February 5, 2015 | 70436 | Class II | Terminated | ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during di | Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr | accessdata.fda.gov |
| January 9, 2015 | 70313 | Class III | Terminated | Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing | Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated. | accessdata.fda.gov |
| January 5, 2015 | 70177 | Class II | Terminated | ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement. | The product labeling does not specify the 5 year shelf life of the product. | accessdata.fda.gov |
| January 2, 2015 | 70175 | Class II | Terminated | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins. | Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user. | accessdata.fda.gov |
| December 16, 2014 | 70017 | Class II | Terminated | Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tub | the Instructions for Use (IFU) were inadvertently removed from the kit. | accessdata.fda.gov |
| November 10, 2014 | 69740 | Class II | Terminated | Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported. | accessdata.fda.gov |
| September 18, 2014 | 69290 | Class II | Terminated | Multi-Lumen Central Venous Catheterization Kit | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expirati | accessdata.fda.gov |
| September 15, 2014 | 69256 | Class II | Terminated | ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit | Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass. | accessdata.fda.gov |
| August 6, 2014 | 68987 | Class II | Terminated | Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. | The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility. | accessdata.fda.gov |
| April 14, 2014 | 68073 | Class II | Terminated | Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation. | Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage. | accessdata.fda.gov |
| March 24, 2014 | 67831 | Class II | Terminated | Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter. | Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter. | accessdata.fda.gov |
| November 8, 2013 | 70603 | Class II | Terminated | Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS | Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere. | accessdata.fda.gov |
| October 9, 2013 | 66589 | Class II | Terminated | Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or anal | A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin. | accessdata.fda.gov |
| October 9, 2013 | 66586 | Class II | Terminated | Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. | There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient. | accessdata.fda.gov |
| July 31, 2013 | 65829 | Class II | Terminated | Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients. | Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen. | accessdata.fda.gov |
| July 17, 2013 | 67834 | Class II | Terminated | Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. | Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM | accessdata.fda.gov |
| July 17, 2013 | 67833 | Class II | Terminated | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF. | The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinic | accessdata.fda.gov |
| March 4, 2013 | 64593 | Class II | Terminated | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac ang | The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care provide | accessdata.fda.gov |
| February 4, 2013 | 69938 | Class II | Terminated | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-S | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. | accessdata.fda.gov |
| November 27, 2012 | 64527 | Class II | Terminated | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy. | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. | accessdata.fda.gov |
| June 7, 2012 | 62125 | Class II | Terminated | Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central c | Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover. | accessdata.fda.gov |
| May 3, 2012 | 61915 | Class I | Terminated | Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation. | Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status. | accessdata.fda.gov |
| June 28, 2011 | 59212 | Not yet classified | Terminated | Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis. | Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters. | accessdata.fda.gov |
| June 20, 2011 | 60314 | Not yet classified | Terminated | Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039 Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques f | Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed. | accessdata.fda.gov |
| June 17, 2011 | 59113 | Not yet classified | Terminated | Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for perio | Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed. | accessdata.fda.gov |
| March 25, 2011 | 58331 | Not yet classified | Terminated | Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system | Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging. | accessdata.fda.gov |
| December 20, 2010 | 57572 | Not yet classified | Terminated | Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedure | Packaging may have been compromised, and sterility of product cannot be guaranteed. | accessdata.fda.gov |
| November 11, 2010 | 57259 | Not yet classified | Terminated | Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit | Sterility may be compromised. | accessdata.fda.gov |
| November 9, 2010 | 57218 | Not yet classified | Terminated | Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. Permits venous access to the central circulation. | One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit. | accessdata.fda.gov |
| October 29, 2010 | 57287 | Not yet classified | Terminated | SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH-03000, KC-03000, SA-03001 and SH-03001. Epidural Anesthesia Kit | Sterility may be compromised. | accessdata.fda.gov |
| July 29, 2010 | 56363 | Not yet classified | Terminated | MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle | accessdata.fda.gov |
| June 7, 2010 | 55933 | Not yet classified | Terminated | Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801 | Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed. | accessdata.fda.gov |
| March 29, 2010 | 55385 | Not yet classified | Terminated | Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-014 | Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. If the catheter will not pass through the sheath, the clinician is required to place a guide wire back | accessdata.fda.gov |
| February 1, 2010 | 54723 | Not yet classified | Terminated | IV Sets and Accessories, various configurations. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, pl | Sterility may be compromised. | accessdata.fda.gov |
| December 15, 2009 | 54091 | Not yet classified | Terminated | Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605 Permits venous access and catheter i | Some central venous catheter sets had the incorrect lid stock. | accessdata.fda.gov |
| November 24, 2009 | 53954 | Not yet classified | Terminated | MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The product is shi | Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter. | accessdata.fda.gov |
| June 17, 2009 | 52388 | Not yet classified | Terminated | Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502. | The spring wire guide is too large in diameter to pass through the needle, dilator and catheter. | accessdata.fda.gov |
| May 8, 2009 | 52376 | Not yet classified | Terminated | 12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rap | Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter. | accessdata.fda.gov |
| March 25, 2009 | 51960 | Not yet classified | Terminated | Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended f | The inflation arm tubing may separate from the stopcock adapter. | accessdata.fda.gov |
Compare with other makers
- All makers of Anesthesia Conduction Kit
- All makers of Catheter, Percutaneous
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Electrode, Pacemaker, Temporary
Updated March 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.