Recall archive
25 recalls · page 1 of 2
Reported May 18, 2022
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 2, 2022
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system.…
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand — During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 4, 2021
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped…
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular, Inc.
Matched: Brand — Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
FDA (openFDA device enforcement)
Reported Mar 17, 2021
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular
Matched: Brand · Product · Product details — Sterility may be compromised due to an unsealed pouch
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2020
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — Subsequent failure of catheters in the field and failed quality testing
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand · Product · Product details · Reason for recall — Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
FDA (openFDA device enforcement)
Reported Oct 23, 2019
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand · Reason for recall — Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa…
190 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Vascular
Matched: Brand · Product · Product details · Reason for recall — Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French…
FDA (openFDA device enforcement)
Reported May 2, 2018
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Oct 4, 2017
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Sep 27, 2017
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand — Stylette removal difficulties on the Euphora and Solarice products.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product details · Reason for recall — Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Reason for recall — Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the…
FDA (openFDA device enforcement)
Reported Nov 19, 2014
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular
Matched: Brand · Product · Product details — Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the…
FDA (openFDA device enforcement)
Reported Apr 2, 2014
FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in (…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product details · Reason for recall — Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Vascular
Matched: Brand · Product · Product details — Incorrect master label.
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand · Product details — Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Product details — A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart…
FDA (openFDA device enforcement)
Reported Nov 6, 2013
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand — Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
FDA (openFDA device enforcement)
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