Micro Therapeutics Inc, Dba Ev3 Neurovascular

Complete recall history across all FDA and CPSC categories — 14 total recalls

Micro Therapeutics Inc, Dba Ev3 Neurovascular appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Micro Therapeutics Inc, Dba Ev3 Neurovascular

Date Product Reason Class
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... Class I
Feb 14, 2020 ev3 Pipeline Flex Embolization Device. For neurological endovascular use. Embolization device delivery system may fracture at the distal section during... Class I
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... Class II
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 det... Class I
Oct 5, 2016 Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cath... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating mat... Class I
Oct 5, 2016 X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating mat... Class I
Oct 5, 2016 Alligator Retrieval Device The device is intended for use in the peripheral ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating mat... Class I
Oct 5, 2016 Pipeline Embolization Device (Pipeline Classic) The device is indicated for ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating mat... Class I
Sep 4, 2015 -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipe... The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.... Class II
Apr 1, 2014 Pipeline Embolization Device (PED). Used endovascular treatment of adults wi... Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and de... Class I
Apr 1, 2014 Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculatur... Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and de... Class I
Jul 19, 2013 Pipeline Embolization Device (PED) The Pipeline Embolization Device is ind... Covidien Neurovascular has initiated the recall of several lots of Pipeline E... Class II
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 ... Class II
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 ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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