Medtronic Vascular, Inc.

Complete recall history across all FDA and CPSC categories — 19 total recalls

Medtronic Vascular, Inc. 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 (19)

FDA medical device enforcement actions by Medtronic Vascular, Inc.

Date Product Reason Class
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
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
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 ... Class II
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... Class II
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 ... Class II
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... Class II
Jun 7, 2021 Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Gra... During product complaint investigation, it was determined that during stent g... Class II
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 ... Class II
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 com... Class II
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 e... Class I
Sep 13, 2017 Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... It was determined that the deflection length indicated on the Guide catheter ... Class II
Feb 27, 2017 Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Nu... Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset... Class II
Oct 23, 2015 Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 A... Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon D... Class II
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embol... Class II
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embol... Class II
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embol... Class II
Oct 7, 2013 Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Sten... A small number of units in lot number 0006573585 of the Resolute Integrity Zo... Class II
Sep 16, 2013 NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm... Class II
Sep 19, 2012 Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic ... Firm received reports of difficulty in flushing the graft cover of the delive... 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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