Data / Medical devices / United States / Merit Medical Systems, Inc.
Merit Medical Systems, Inc.: FDA-registered device maker in South Jordan, UT, United States, 188 510(k) clearances and 1 PMA approval
Merit Medical Systems, Inc. is registered with the FDA (registration 1721504) in South Jordan, UT, United States. It lists 122 device types. The FDA files 188 510(k) clearances and 1 PMA approval under its listings, the newest dated July 27, 2026. 89 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1721504
- Address
- 1600 West Merit Pkwy., South Jordan, UT, United States, 84095
- Owner or operator
- Merit Medical Systems, Inc. (1721504)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- July 14, 1992
- Registered through
- 2027
- Brand names listed
- 1 mL syringe(Polypropylene), 10Fore Hemostasis Valve, 10Fore Hemostasis Valve Kit, 5.5 F Worley Advanced LVI Lateral Vein Introducer, AEROmini Tracheobronchial Stent System, ARC Catheter, ASAP Aspiration Catheter, ASAP CATHETER 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 188.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 27, 2026 | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | DRE | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| February 13, 2026 | K251802 | STAR RF Ablation System | GXI | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 31, 2026 | K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | DQX | Substantially Equivalent | Merit Medical Ireland, Ltd. | accessdata.fda.gov |
| January 21, 2026 | K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | DQX | Substantially Equivalent | Merit Medical Ireland, Ltd. | accessdata.fda.gov |
| December 19, 2025 | K252892 | SCOUT MD Surgical Guidance System | NEU | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 4, 2025 | K250853 | Merit Syringe | FMF | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| September 10, 2025 | K252527 | Surfacer Inside-Out Access Catheter System | QJH | Unknown | Merit Medical System, Inc. | accessdata.fda.gov |
| August 29, 2025 | K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | DQX | Substantially Equivalent | Merit Medical Ireland, Ltd. | accessdata.fda.gov |
| July 23, 2025 | K251265 | Resilience Fully Covered Esophageal Stent System | ESW | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 25, 2025 | K250909 | Prelude Wave Hydrophilic Sheath Introducer | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 15, 2025 | K242873 | Ventrax Delivery System | DQY | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 15, 2025 | K242229 | Micro Ace Gold Advanced Micro Access System | DRE | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| September 16, 2024 | K241762 | OneMark | NEU | Substantially Equivalent | View Point Medical | accessdata.fda.gov |
| July 24, 2024 | K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | GEH | Substantially Equivalent | Pentax of America, Inc. | accessdata.fda.gov |
| May 22, 2024 | K233268 | Impress Angiographic Catheter | DQO | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| May 2, 2024 | K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | KRD | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 26, 2024 | K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | ODE | Substantially Equivalent | Endogastric Solutions, Inc. | accessdata.fda.gov |
| February 12, 2024 | K231468 | SCOUT MD Surgical Guidance System | NEU | Substantially Equivalent | Merit Medical System, Inc. | accessdata.fda.gov |
| October 28, 2023 | K230418 | Mighty Wire Guide Wire | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| September 27, 2023 | K232609 | Micro Ace Advanced Micro Access System | DRE | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 30, 2023 | K230636 | Maestro Microcatheter | KRA | Substantially Equivalent | Merit Medical System, Inc. | accessdata.fda.gov |
| March 3, 2023 | K212696 | Aspira Pleural Drainage System | DWM | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 19, 2023 | K223872 | Low Profile Companion Sheath | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 15, 2022 | K213845 | HeRO Graft | DSY | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 8, 2022 | K212882 | SCOUT BX Delivery System | NEU | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 8, 2022 | K213434 | Elation Pulmonary Balloon Dilation Catheter | KTI | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 7, 2022 | K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer | DYB | Substantially Equivalent | Merit Medical Systems | accessdata.fda.gov |
| December 14, 2021 | K212675 | Aspira Peritoneal Drainage System | PNG | Unknown | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 3, 2021 | K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | QEZ | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| October 4, 2021 | K211405 | Prelude Guide Sheath | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 16, 2021 | K211525 | SwiftNINJA Steerable Microcatheter | KRA | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| May 25, 2021 | K203724 | HeRO Graft, HeRO Adapter | DSY | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| October 14, 2020 | K201595 | Merit Hydrophilic Guide Wire | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 28, 2020 | K201166 | Temno Elite Biopsy System | KNW | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 7, 2020 | K193082 | Fountain ValveTip Infusion Catheter | KRA | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 8, 2020 | K193571 | Go2Wire Guide Wire | DQX | Substantially Equivalent | Merit Medical System, Inc. | accessdata.fda.gov |
| February 10, 2020 | DEN190038 | Surfacer Inside-Out Access Catheter System | QJH | Unknown | Bluegrass Vascular Technologies, Inc. | accessdata.fda.gov |
| January 17, 2020 | K193507 | Merit ONE Snare System | MMX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 22, 2019 | K193036 | C2 CryoBalloon EndoGrip | OCX | Substantially Equivalent | Pentax Medical, A Division of Pentax of America, Inc. | accessdata.fda.gov |
| October 9, 2019 | K191596 | Arcadia Balloon Catheter | HRX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 16, 2019 | K191608 | Impress Angiographic Catheter | DQO | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 10, 2019 | K190175 | S-MAK XL | DRE | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 14, 2019 | K181669 | ConvertX Biliary Stent System | FGE | Substantially Equivalent | Brightwater Medical | accessdata.fda.gov |
| November 6, 2018 | K182279 | Merit Syringe | FMF | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 6, 2018 | K182216 | Merit Syringe | FMF | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| September 21, 2018 | K181200 | AEROmini Tracheobronchial Stent System | JCT | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 2, 2018 | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | NEU | Substantially Equivalent | Cianna Medical, Inc. | accessdata.fda.gov |
| April 17, 2018 | K180723 | PreludeSYNC DISTAL Radial Compression System | DXC | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 30, 2018 | K173548 | Merit Pursue Microcatheter | DQY | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 12, 2018 | K180450 | Corvocet Biopsy System | KNW | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| February 15, 2018 | K173750 | Prelude IDeal Hydrophilic Sheath Introducer | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 31, 2018 | K173601 | Merit Syringe | FMF | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 30, 2017 | K172637 | HeRO Graft | DSY | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| October 18, 2017 | K170298 | Liberator Beacon Tip Locking Stylet | DRB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| September 11, 2017 | K172117 | Prelude Pursuit Splittable Sheath Introducer | DYB | Unknown | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 4, 2017 | K172081 | Maestro Microcatheter | KRA | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 27, 2017 | K163597 | VacLok AT Vacuum Syringe | PUR | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 21, 2017 | K170532 | True Form Reshapable Guide Wire | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 11, 2017 | K163353 | Needle's Eye Snare Retrieval Set - 54cm | DXE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| June 22, 2017 | K170933 | Merit Hydrophilic Guide Wire | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| June 15, 2017 | K163084 | Merit Coronary Control Syringe | DXT | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 6, 2017 | K170700 | Inqwire Diagnostic Guide Wire | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 5, 2017 | K170668 | HeartSpan Steerable Sheath Introducer | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 3, 2017 | K163575 | Inqwire Diagnostic Guide Wire | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| January 25, 2017 | K162988 | PreludeSYNC Radial Compression Device | DXC | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 22, 2016 | K161277 | ConvertX Nephroureteral Stent System | FAD | Substantially Equivalent | Brightwater Medical | accessdata.fda.gov |
| November 4, 2016 | K161921 | SwiftNINJA Microcatheter | KRA | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| October 31, 2016 | K162777 | Squirt Fluid Delivery System | QEY | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| September 1, 2016 | K161392 | Elation Pulmonary Balloon Dilation | KTI | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 29, 2016 | K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | DXT | Unknown | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 4, 2016 | K151967 | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter | MSD | Unknown | Merit Medical Systems, Inc. | accessdata.fda.gov |
| March 25, 2016 | K153337 | Corvocet Biopsy System | KNW | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| February 24, 2016 | K152310 | HeartLight Deflectable Sheath | DRA | Substantially Equivalent | Cardiofocus, Inc. | accessdata.fda.gov |
| January 6, 2016 | K153502 | ClariVein IC | KRA | Substantially Equivalent | Vascular Insights, LLC | accessdata.fda.gov |
| December 7, 2015 | K152783 | Merit 20 mL Syringe | FMF | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 6, 2015 | K151925 | Elation Wireguided Balloon Dilation Catheter | FGE | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| October 30, 2015 | K152381 | Prelude SNAP Splittable Hydrophilic Sheath Introducer | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 27, 2015 | K152116 | 5.5 F Worley Advanced LVI Lateral Vein Introducer | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 7, 2015 | K151373 | Corvocet Coaxial Introducer | FCG | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 1, 2015 | K151497 | EN Snare Endovascular Snare System | MMX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| June 19, 2015 | K150257 | PreludeEASE Hydrophilic Sheath Introducer | DYB | Unknown | Merit Medical Systems, Inc. | accessdata.fda.gov |
| May 22, 2015 | K142806 | DualCap | QBP | Substantially Equivalent | Catheter Connections, Inc. | accessdata.fda.gov |
| April 14, 2015 | K150083 | Sidecar External Working Channel | FED | Substantially Equivalent | C2 Therapeutics | accessdata.fda.gov |
| April 9, 2015 | K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | NDN | Substantially Equivalent | Osseon, LLC | accessdata.fda.gov |
| April 9, 2015 | K143255 | Prelude SNAP Splittable Sheath Introducer | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| December 17, 2014 | K142051 | PRELUDE PLASTIC JACKETED GUIDE WIRE | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| December 10, 2014 | K141054 | DISTAL ACCESS TORQUE DEVICE | DQX | Substantially Equivalent | Distal Access, LLC | accessdata.fda.gov |
| November 26, 2014 | K141408 | RESOLVE BILIARY LOCKING DRAINAGE CATHETER | FGE | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 25, 2014 | K140382 | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | JCT | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 13, 2014 | K142265 | ONE Snare Endovascular Microsnare System | MMX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 12, 2014 | K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | DRE | Substantially Equivalent | Cook Vascular, Inc. | accessdata.fda.gov |
| October 16, 2014 | K140543 | PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| September 12, 2014 | K140608 | MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE | DQX | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| September 5, 2014 | K141552 | ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS | KNW | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| August 21, 2014 | K141930 | OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML | NDN | Substantially Equivalent | Osseon, LLC | accessdata.fda.gov |
| July 9, 2014 | K140513 | MERIT SAFETY INTRODUCER NEEDLE | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| July 1, 2014 | K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE | Substantially Equivalent | Cook Vascular, Inc. | accessdata.fda.gov |
| June 19, 2014 | K140937 | OSSEOFLEX SB | NDN | Substantially Equivalent | Osseon, LLC | accessdata.fda.gov |
| June 18, 2014 | K141363 | CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER | MSD | Unknown | Merit Medical Systems, Inc. | accessdata.fda.gov |
| February 14, 2014 | K131260 | NMI DIALYSIS CATHETER | MSD | Unknown | Navilyst Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 19, 2024 | P240023 | WRAPSODY® Cell-Impermeable Endoprosthesis | PFV | 4 | June 11, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 27, 2026 | 99901 | Class II | Ongoing | Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO | The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. | accessdata.fda.gov |
| August 10, 2026 | 99541 | Class II | Ongoing | Embosphere micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/ | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection. | accessdata.fda.gov |
| May 8, 2026 | 98818 | Class II | Ongoing | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 0088445052968 | Due to unsealed portions of pouches. | accessdata.fda.gov |
| April 2, 2026 | 98637 | Class II | Ongoing | Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY | catheter may experience resistance when being advanced over the guidewire | accessdata.fda.gov |
| February 13, 2026 | 98464 | Class I | Ongoing | CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT1 | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | accessdata.fda.gov |
| December 4, 2025 | 98139 | Class II | Ongoing | Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K | Inflation device handle may detach from the syringe during procedure. | accessdata.fda.gov |
| August 4, 2025 | 97446 | Class II | Ongoing | PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY18 | Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage. | accessdata.fda.gov |
| July 25, 2025 | 97420 | Class II | Ongoing | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/w | Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. | accessdata.fda.gov |
| June 5, 2025 | 97151 | Class II | Ongoing | High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | accessdata.fda.gov |
| March 14, 2025 | 96482 | Class II | Ongoing | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. | accessdata.fda.gov |
| January 27, 2025 | 96292 | Class II | Ongoing | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. | accessdata.fda.gov |
| August 30, 2024 | 95330 | Class II | Ongoing | Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pr | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | accessdata.fda.gov |
| August 19, 2024 | 95343 | Class II | Ongoing | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | accessdata.fda.gov |
| August 12, 2024 | 95234 | Class II | Ongoing | Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) | 7F sheath introducers labeled as 7.5F | accessdata.fda.gov |
| June 11, 2024 | 94797 | Class II | Ongoing | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | accessdata.fda.gov |
| May 22, 2024 | 94684 | Class II | Ongoing | Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90 | Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body. | accessdata.fda.gov |
| March 14, 2024 | 94304 | Class II | Ongoing | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY | Their is a potential that sheaths labeled with.018 dilators may contain a.038 dilator. | accessdata.fda.gov |
| November 6, 2023 | 93461 | Class II | Ongoing | Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC2 | The sterility of microcatheter and infusion system devices cannot be guaranteed. | accessdata.fda.gov |
| April 22, 2023 | 92301 | Class II | Ongoing | Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only | There is a potential that valve assemblies will not open. preventing fluid from draining. | accessdata.fda.gov |
| March 21, 2023 | 92042 | Class II | Ongoing | COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units | Custom sheath Introducer contains incorrect needle size | accessdata.fda.gov |
| February 15, 2023 | 91852 | Class II | Ongoing | Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A | Product that was built for design verification testing was inadvertently distributed to customers. | accessdata.fda.gov |
| August 3, 2022 | 90804 | Class II | Ongoing | CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B | Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury. | accessdata.fda.gov |
| March 1, 2022 | 89815 | Class II | Ongoing | Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-1 | A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure. | accessdata.fda.gov |
| July 21, 2021 | 88352 | Class II | Terminated | MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391 | There is a potential that a package sheath contains an incorrect dilator. | accessdata.fda.gov |
| June 30, 2021 | 88315 | Class II | Terminated | Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the h | There is a potential that 7F sheaths are packaged as 10F sheaths. | accessdata.fda.gov |
| June 10, 2021 | 88191 | Class II | Terminated | basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon. | Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. | accessdata.fda.gov |
| January 19, 2021 | 87306 | Class II | Terminated | HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock | The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention. | accessdata.fda.gov |
| November 10, 2020 | 86831 | Class II | Terminated | Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bow | Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment. | accessdata.fda.gov |
| September 16, 2020 | 86522 | Class II | Terminated | MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106 | The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment. | accessdata.fda.gov |
| March 11, 2020 | 85292 | Class II | Terminated | PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT | During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or ide | accessdata.fda.gov |
| February 13, 2020 | 85485 | Class II | Terminated | DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphop | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a d | accessdata.fda.gov |
| September 12, 2019 | 85342 | Class II | Terminated | Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein. | labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism. | accessdata.fda.gov |
| October 26, 2018 | 83738 | Class II | Terminated | Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409 | Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free) | accessdata.fda.gov |
| July 9, 2018 | 85171 | Class II | Terminated | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. | A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer. | accessdata.fda.gov |
| February 2, 2018 | 80650 | Class II | Terminated | 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body. | Supplier manufacturing defect with the syringe plunger tip. | accessdata.fda.gov |
| December 20, 2017 | 80651 | Class II | Terminated | Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted either surgically or perit | Mix-up between adult and pediatrics PD catheter. | accessdata.fda.gov |
| December 14, 2017 | 78961 | Class II | Terminated | PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS | Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub. | accessdata.fda.gov |
| September 20, 2017 | 79426 | Class II | Terminated | Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B | 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. | accessdata.fda.gov |
| March 23, 2017 | 76938 | Class II | Terminated | 1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P. | Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a defect with the syringe plunger tip. | accessdata.fda.gov |
| March 3, 2017 | 76762 | Class II | Terminated | The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft | Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve. | accessdata.fda.gov |
| February 16, 2017 | 76596 | Class I | Terminated | 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous | Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use. | accessdata.fda.gov |
| December 1, 2016 | 75999 | Class II | Terminated | PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteri | Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire. | accessdata.fda.gov |
| September 23, 2016 | 75367 | Class II | Terminated | Fluid Management Set. Catalog Number K08-MP5159A | Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier. | accessdata.fda.gov |
| August 25, 2016 | 75127 | Class II | Terminated | Merit Inflation Syringe Kit. Catalog Number KOS-02857 | Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information. | accessdata.fda.gov |
| August 12, 2016 | 75011 | Class II | Terminated | Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system. | Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber. | accessdata.fda.gov |
| March 15, 2016 | 73630 | Class II | Terminated | Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the hear | Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50 curve, rather than the correct 86 curve | accessdata.fda.gov |
| June 29, 2015 | 71694 | Class II | Terminated | ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities. | Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package. | accessdata.fda.gov |
| June 4, 2015 | 71519 | Class II | Terminated | Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devic | Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038. | accessdata.fda.gov |
| September 26, 2014 | 69452 | Class II | Terminated | Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged. | These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. | accessdata.fda.gov |
| April 14, 2014 | 68041 | Class II | Terminated | Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102"). | Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit label | accessdata.fda.gov |
| March 13, 2014 | 67844 | Class II | Terminated | Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer. | The products are labeled as sterile but were not sterilized. | accessdata.fda.gov |
| December 18, 2013 | 67206 | Class II | Terminated | Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD wa | Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure pa | accessdata.fda.gov |
| December 6, 2013 | 67128 | Class II | Terminated | Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used f | Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match. | accessdata.fda.gov |
| September 13, 2013 | 66400 | Class II | Terminated | Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3. | 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. | accessdata.fda.gov |
| May 2, 2013 | 65150 | Class II | Terminated | Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine | Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape. | accessdata.fda.gov |
| January 16, 2013 | 64202 | Class II | Terminated | Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system. | A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization. | accessdata.fda.gov |
| December 17, 2010 | 57540 | Not yet classified | Terminated | Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. Intended to provide access and facilitate the percutaneous introduction of various devices into veins | Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response. | accessdata.fda.gov |
| November 17, 2010 | 57418 | Not yet classified | Terminated | Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids | The catheter's valved hub may fail resulting in an inability to drain fluid. | accessdata.fda.gov |
| October 25, 2010 | 57176 | Not yet classified | Terminated | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint. | accessdata.fda.gov |
| October 22, 2010 | 57102 | Not yet classified | Terminated | VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. | Packaging for syringes may have holes which would compromise the sterility of the package contents. | accessdata.fda.gov |
| September 9, 2010 | 56756 | Not yet classified | Terminated | Control Syringe, 12ml, CAT No: CCS600 Version B, Sterile R, Merit Medical Systems, Inc. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used | Small holes in the packaging may render the product non-sterile. | accessdata.fda.gov |
| June 28, 2010 | 56161 | Not yet classified | Terminated | Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnost | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. | accessdata.fda.gov |
| May 5, 2010 | 55661 | Not yet classified | Terminated | Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected | Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands. | accessdata.fda.gov |
| January 28, 2010 | 54485 | Not yet classified | Terminated | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary t | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. | accessdata.fda.gov |
| January 6, 2010 | 54228 | Not yet classified | Terminated | Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. | Infusion catheters may become brittle and break during use. | accessdata.fda.gov |
| September 29, 2009 | 53557 | Not yet classified | Terminated | Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainage bag | Potential sterility breach caused by excessive shipment damage. | accessdata.fda.gov |
| April 14, 2009 | 51877 | Not yet classified | Terminated | Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various d | External tubing may separate during use, allowing blood loss. | accessdata.fda.gov |
| January 29, 2009 | 51104 | Not yet classified | Terminated | University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization i | A manufacturing defect may prevent adequate sterilization of the entire device. | accessdata.fda.gov |
| November 7, 2008 | 50193 | Not yet classified | Terminated | ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system. | Biliary drainage catheter tips may separate from the catheter shaft after placement. | accessdata.fda.gov |
| September 12, 2008 | 49526 | Not yet classified | Terminated | Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 | Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at. | accessdata.fda.gov |
| July 9, 2008 | 49002 | Not yet classified | Terminated | 10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and | Control Syringes may be non-sterile due to holes in the packaging. | accessdata.fda.gov |
| May 14, 2008 | 48445 | Not yet classified | Terminated | Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral | Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient. | accessdata.fda.gov |
| April 15, 2008 | 47891 | Not yet classified | Terminated | Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. | Convenience kits may be non-sterile due to inadequate package sealing. | accessdata.fda.gov |
| April 10, 2008 | 47881 | Not yet classified | Terminated | Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the | Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility. | accessdata.fda.gov |
| April 8, 2008 | 47880 | Not yet classified | Terminated | Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline f | Convenience kits may contain non-filtered drip chambers. | accessdata.fda.gov |
| March 14, 2008 | 48658 | Not yet classified | Terminated | CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one conta | Component of convenience kit may not be sterile. | accessdata.fda.gov |
| August 15, 2007 | 38950 | Not yet classified | Terminated | Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10 | Expiration Dating; Some Convenience Kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label. | accessdata.fda.gov |
| April 17, 2007 | 37902 | Not yet classified | Terminated | Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095. | Male luer in fluid administration sets may crack due to inadequate molding process | accessdata.fda.gov |
| February 15, 2007 | 37422 | Not yet classified | Terminated | StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain. | Sterility of some units may be compromised due to damaged packaging. | accessdata.fda.gov |
| November 7, 2005 | 34082 | Not yet classified | Terminated | IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. | accessdata.fda.gov |
| October 21, 2005 | 33954 | Not yet classified | Terminated | Viceroy Inflation Syringe, 60mL, Sterile, Rx only. | Inflation device may not hold vacuum during angioplasty procedure. | accessdata.fda.gov |
| September 2, 2005 | 33364 | Not yet classified | Terminated | Merit Custom Procedure Kit | Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure. | accessdata.fda.gov |
| October 15, 2004 | 30343 | Not yet classified | Terminated | Safety Paracentesis Procedure Tray | Merit Safety Paracentesis Procedure Trays contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use. | accessdata.fda.gov |
| September 14, 2004 | 30119 | Not yet classified | Terminated | 8 ml Inject8 Coronary Control Syringe, sterile. | Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch. | accessdata.fda.gov |
| July 20, 2004 | 29651 | Not yet classified | Terminated | Merit MAK Mini Access Kit, 4 French (1.3mm) | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. | accessdata.fda.gov |
| November 5, 2003 | 27749 | Not yet classified | Terminated | UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical. | Angiographic catheter tips may separate during use. | accessdata.fda.gov |
| October 1, 2003 | 27525 | Not yet classified | Terminated | Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL. Sterile if package is unopened or undamaged. Part # IN2125/B. | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays. | accessdata.fda.gov |
| May 16, 2003 | 26356 | Not yet classified | Terminated | Inject 10 Coronary Control Syringe (CCS), 10ml | Cracks in the syringe barrels could allow for air aspiration into the syringe barrel. | accessdata.fda.gov |
| February 13, 2003 | 25605 | Not yet classified | Terminated | Custom Angiographic Kit. | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. | accessdata.fda.gov |
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Updated October 15, 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.