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Medtronic Vascular Recalls
230 recalls on record · October 9, 2013 to May 18, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 2, 2018Medical DevicesFDA
Medtronic Vascular recalls Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Hazard: The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
October 4, 2017Medical DevicesFDA
Medtronic Vascular, Inc. recalls Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Hel
Hazard: It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.
March 29, 2017Medical DevicesFDA
Medtronic Vascular, Inc. recalls Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF
Hazard: Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
November 18, 2015Medical DevicesFDA
Medtronic Vascular, Inc. recalls Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP04
Hazard: Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
November 19, 2014Medical DevicesFDA
Medtronic Vascular recalls Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Hazard: Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the
April 2, 2014Medical DevicesFDA
Medtronic Vascular, Inc. recalls FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.3
Hazard: Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.
April 2, 2014Medical DevicesFDA
Medtronic Vascular, Inc. recalls FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.3
Hazard: Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.
April 2, 2014Medical DevicesFDA
Medtronic Vascular, Inc. recalls FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.
Hazard: Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.
March 5, 2014Medical DevicesFDA
Medtronic Vascular recalls Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device i
Hazard: Incorrect master label.
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for th
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable g
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medt
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steer
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNG
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
November 27, 2013Medical DevicesFDA
Medtronic Vascular recalls Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRX
Hazard: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
November 13, 2013Medical DevicesFDA
Medtronic Vascular, Inc. recalls Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtro
Hazard: A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.
November 6, 2013Medical DevicesFDA
Medtronic Vascular, Inc. recalls Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery Syst
Hazard: Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
October 9, 2013Medical DevicesFDA
Medtronic Vascular, Inc. recalls NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic,
Hazard: Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.