Data / Medical devices / United States / Angiodynamics, Inc.
Angiodynamics, Inc.: FDA-registered device maker in Queensbury, NY, United States, 63 510(k) clearances
Angiodynamics, Inc. is registered with the FDA (registration 1319211) in Queensbury, NY, United States. It lists 25 device types. The FDA files 63 510(k) clearances under its listings, the newest dated March 24, 2026. 28 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1319211
- Address
- 603 Queensbury Ave., Queensbury, NY, United States, 12804
- Owner or operator
- ANGIODYNAMICS, INC (9028212)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- February 8, 2000
- Registered through
- 2026
- Brand names listed
- 16 Gauge Entry Needle, Accu-Vu Sizing Catheters, AlphaVac MMA F1885 System, AlphaVac Multipurpose Mechanical Aspiration (MMA) System, AlphaVac Multipurpose Mechanical Aspiration (MMA) System F18 85, AlphaVac Multipurpose Mechanical Aspiration System F1885, AngiOptic Angiographic Catheters, AngioVac 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2026 | K253198 | NanoKnife Generator (H78720300351US0) | OAB | Substantially Equivalent | Angiodynamics | accessdata.fda.gov |
| November 24, 2025 | K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| October 24, 2025 | K253106 | AngioVac Cannula | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 6, 2024 | K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | OAB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| April 1, 2024 | K240397 | AlphaVac MMA F1885 System (H787253020) | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 20, 2023 | K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 27, 2023 | K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 7, 2023 | K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| April 4, 2022 | K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 3, 2021 | K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| September 30, 2021 | K212386 | AngioVac F18 85 | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 4, 2021 | K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| September 15, 2020 | K202347 | UNIFUSE Infusion System with Cooper Wire | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 1, 2020 | K192864 | UNI*FUSE Infusion System with Cooper Wire | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 22, 2020 | K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | LJT | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 5, 2019 | K190594 | AngioVac C20, AngioVac C180 | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 18, 2019 | K183385 | NanoKnife System | OAB | Substantially Equivalent | Angiodynamics | accessdata.fda.gov |
| February 28, 2019 | K182250 | Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 18, 2018 | K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters | DQO | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 5, 2018 | K181044 | 400um Perforator and Accessory Vein Ablation Kit | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| August 24, 2017 | K171921 | VenaCure EVLT NeverTouch Procedure Kit | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 19, 2017 | K170775 | Mini Stick ENVI Non-Vascular Introducer Kit | DYB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 30, 2017 | K170695 | VenaCure EVLT NeverTouch Direct Introducer Sheath | DYB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 30, 2017 | K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 5, 2017 | K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| April 28, 2017 | K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | DQO | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 30, 2017 | K170743 | AngioDynamics Total Abscession Biliary Drainage Catheter | FGE | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| February 21, 2017 | K170258 | SpeedLyser Infusion Catheter Kit | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| November 16, 2016 | K162914 | VenaCure EVLT NeverTouch Procedure Kit | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 6, 2016 | K151239 | NMI DUAL PORT II | LJT | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| December 4, 2015 | K153228 | NMI Port, NMI Port II | LJT | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| September 24, 2015 | K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter | FGE | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| June 18, 2015 | K150089 | NanoKnife System | OAB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 11, 2014 | K142607 | AngioVac Circuit | DWE | Substantially Equivalent | Angiodynamics | accessdata.fda.gov |
| November 12, 2014 | K142593 | AngioVac Cannula | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| October 10, 2014 | K142614 | AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure Kits | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| September 27, 2013 | K132713 | NMI COAXIAL MICROINTRODUCER SET | DRE | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| August 8, 2013 | K131694 | NMI PORT II CATHETER | LJT | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| March 26, 2013 | K130671 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 30, 2012 | K112452 | ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS | DQO | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| January 30, 2012 | K112600 | ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 15, 2010 | K102796 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 17, 2010 | K101017 | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS | LJT | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| February 1, 2007 | K062414 | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET | LJT | Substantially Equivalent | Rita Medical Systems, Inc. | accessdata.fda.gov |
| September 12, 2005 | K051655 | ANGIODYNAMICS, INC., MICRO ACCESS KITS | DQR | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 1, 2004 | K041957 | EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS | GEX | Substantially Equivalent | Diomed, Inc. | accessdata.fda.gov |
| November 18, 2003 | K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| September 9, 2003 | K032557 | TRIUMPH VTX WITH LIFEVALVE CATHETER | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| March 29, 2002 | K013871 | LIFEGUARD SAFETY INFUSION SET | FPA | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| April 10, 2001 | K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| February 12, 2001 | K010189 | VORTEX ACCESS SYSTEM | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| March 13, 1998 | K974640 | COAXIAL DILATOR SET | DRE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 2, 1996 | K961088 | NON-CORING NEEDLE | FMI | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 26, 1996 | K953529 | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM | LJT | Substantially Equivalent | Strato/Infusaid, Inc. | accessdata.fda.gov |
| August 29, 1995 | K951814 | TRIUMPH-1 PORT | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| July 7, 1993 | K915273 | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| September 23, 1992 | K921674 | LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE | FPA | Substantially Equivalent | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905852 | STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905850 | STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905849 | STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905845 | STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905839 | STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 15, 1991 | K911355 | LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 | LJT | Substantially Equivalent | Strato Medical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 3, 2026 | 98463 | Class II | Ongoing | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10 | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | accessdata.fda.gov |
| February 4, 2025 | 96192 | Class II | Ongoing | IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60 | Product is mislabeled with the incorrect fill volume. | accessdata.fda.gov |
| November 25, 2024 | 95640 | Class II | Ongoing | AURYON LASER SYSTEM VAC. Model Number: EXM001. Product Number: EXM-2001-1100 | Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode. | accessdata.fda.gov |
| June 18, 2024 | 94903 | Class II | Ongoing | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702 | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) | accessdata.fda.gov |
| May 21, 2024 | 94773 | Class II | Ongoing | IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100 | A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml). | accessdata.fda.gov |
| March 18, 2024 | 94349 | Class II | Ongoing | DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015 | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | accessdata.fda.gov |
| January 30, 2024 | 94035 | Class II | Ongoing | MINI STICK MAX 4F X 10 CM STD.018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749 | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to | accessdata.fda.gov |
| December 18, 2023 | 93744 | Class II | Ongoing | PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 1250042 | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. | accessdata.fda.gov |
| March 2, 2023 | 91909 | Class II | Ongoing | NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110 | Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure | accessdata.fda.gov |
| September 20, 2022 | 90924 | Class II | Ongoing | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury. | accessdata.fda.gov |
| August 10, 2022 | 90811 | Class II | Ongoing | VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins. | OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention | accessdata.fda.gov |
| July 20, 2021 | 88444 | Class II | Terminated | Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. | accessdata.fda.gov |
| October 14, 2020 | 86627 | Class II | Terminated | Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355 | 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component | accessdata.fda.gov |
| May 4, 2020 | 85631 | Class II | Terminated | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vascula | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. | accessdata.fda.gov |
| April 24, 2020 | 88679 | Class II | Terminated | AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103 | Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator. | accessdata.fda.gov |
| November 19, 2019 | 84382 | Class II | Terminated | OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation th | May result in readings outside of the expected accuracy range. | accessdata.fda.gov |
| June 27, 2019 | 83334 | Class II | Terminated | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS.018 PROCEDURE KIT PG, Catalog Number 11403012 | The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used. | accessdata.fda.gov |
| September 22, 2017 | 79193 | Class II | Terminated | Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm.035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated. | Product was placed into distribution prior to completion of all required post sterilization release activities. | accessdata.fda.gov |
| June 5, 2017 | 77631 | Class II | Terminated | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog #, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Ap | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator. | accessdata.fda.gov |
| September 28, 2016 | 75420 | Class II | Terminated | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) h | accessdata.fda.gov |
| August 6, 2014 | 68980 | Class II | Terminated | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). | accessdata.fda.gov |
| April 30, 2013 | 65119 | Class II | Terminated | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size. | accessdata.fda.gov |
| April 4, 2011 | 59825 | Not yet classified | Terminated | ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control bleeding by the use of high- frequency electrical current (s | Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture. | accessdata.fda.gov |
| January 24, 2011 | 59833 | Not yet classified | Terminated | DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. The A | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | accessdata.fda.gov |
| May 17, 2010 | 55715 | Not yet classified | Terminated | PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804. Infusion Catheter. | This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire. | accessdata.fda.gov |
| April 30, 2010 | 55713 | Not yet classified | Terminated | ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804. | Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition. | accessdata.fda.gov |
| January 8, 2010 | 55701 | Not yet classified | Terminated | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog Number/REF 10302802, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test. | accessdata.fda.gov |
| July 7, 2008 | 49042 | Not yet classified | Terminated | Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm From Tip), Catalog No./REF 10303101. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, INC. Queensbury, NY U | The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site. | accessdata.fda.gov |
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Updated April 17, 2026. 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.