Browse Device Recalls
14 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 14 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 14 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For ... | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Aug 10, 2018 | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL... | The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible ... | Class II | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 26, 2018 | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 3... | There is a potential issue for all MindFrame Capture devices to partially detach or separate from... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cath... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | Alligator Retrieval Device The device is intended for use in the peripheral ... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Oct 5, 2016 | Pipeline Embolization Device (Pipeline Classic) The device is indicated for ... | Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Sep 4, 2015 | -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipe... | The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices... | Class II | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Apr 1, 2014 | Pipeline Embolization Device (PED). Used endovascular treatment of adults wi... | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Apr 1, 2014 | Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculatur... | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Jul 19, 2013 | Pipeline Embolization Device (PED) The Pipeline Embolization Device is ind... | Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (... | Class II | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Sep 23, 2011 | UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usag... | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... | Class II | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Sep 23, 2011 | Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The... | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... | Class II | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
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.