CLASS II ONGOING Device recall · Reported 1 Dec 2021 · FDA Enforcement Report
Endurant Stent Graft System recalled by Medtronic Vascular
Medtronic Vascular is recalling Endurant Stent Graft System, distributed nationwide in the US. The recall was initiated on 15 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0290-2022
- FDA event ID
- 88951
- Recalling firm
- Medtronic Vascular, Santa Rosa, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Oct 2021
- FDA classified
- 24 Nov 2021
- Reported
- 1 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 15 Oct 2021 | Recall initiated by company | |
| 24 Nov 2021 | Classified by FDA | +40 days |
| 1 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Product as listed by the FDA
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Nationwide CaliforniaFloridaGeorgiaMinnesotaMissouriNorth CarolinaNew JerseyNew MexicoNevadaNew YorkPennsylvaniaSouth CarolinaTennesseeTexasVirginiaWest Virginia
Questions about this recall
Why was it recalled?
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Which lots are affected?
Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88951This product is part of a recall event; the main page for the event is Endurant II Stent Graft System recalled by Medtronic Vascular.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Endurant II Stent Graft System recalled by Medtronic Vascular | Medtronic Vascular | Other | Nationwide | |
| CLASS II | Endurant IIs Stent Graft System recalled by Medtronic Vascular | Medtronic Vascular | Other | Nationwide |
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All 227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon recalled | Medtronic Vascular | Sterility | Nationwide |
| Device | CLASS II | Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter recalled | Medtronic Vascular | Sterility | Nationwide |
| Device | CLASS II | Endurant IIs Stent Graft System recalled by Medtronic Vascular | Medtronic Vascular | Other | Nationwide |
| Device | CLASS II | Endurant II Stent Graft System recalled by Medtronic Vascular | Medtronic Vascular | Other | Nationwide |
| Device | CLASS II | Medtronic Endurant IIs Stent Graft System Medtronic recalled | Medtronic Vascular | Other | 8 states |
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