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Browse Device Recalls

235 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 235 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 235 FDA device recalls.

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DateProductReasonClassFirm
Mar 23, 2022 Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Mar 23, 2022 Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Dec 21, 2021 Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endur... Stent Graft Systems built with specific batches of taper tip assemblies have the potential for th... Class II Medtronic Vascular, Inc.
Oct 15, 2021 Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT E... Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... Class II Medtronic Vascular, Inc.
Oct 15, 2021 Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF... During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube Class II Medtronic Vascular, Inc.
Oct 15, 2021 Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ET... Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... Class II Medtronic Vascular, Inc.
Jun 7, 2021 Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Gra... During product complaint investigation, it was determined that during stent graft deployment, the... Class II Medtronic Vascular, Inc.
Jun 7, 2021 Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent G... During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of th... Class II Medtronic Vascular, Inc.
May 4, 2021 Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000... The component part numbers intended for shipment to a third-party, where they are further process... Class I Medtronic Vascular
Apr 28, 2021 Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. ... Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device... Class II Medtronic Vascular, Inc.
Feb 12, 2021 Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesio... Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. Class I Medtronic Vascular, Inc.
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
May 12, 2020 Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c... Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) Class I Medtronic Vascular Galway DBA Medtronic Ireland
Sep 3, 2019 Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Sep 3, 2019 Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for ca... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.5, .070", REF SA6SL35. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. for cardiov... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.