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Abre™
MEDTRONIC, INC. · Model AB9U12080090 · UDI-DI 00643169796232
QAN
Prescription
0
510(k) clearances
1,289
Adverse events (7 deaths)
9
Recalls
17
Facilities
Description
STENT AB9U12080090 ABRE V01
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-04 | Medtronic Inc | Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. |
| 2024-02-16 | Medtronic Inc. | There is a potential for sterile package breach. |
| 2021-11-19 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | There have been reports of stent migration. |
| 2021-04-12 | Boston Scientific Corporation | The firm has received reports of stent migration after implantation |
| 2021-04-12 | Boston Scientific Corporation | The firm has received reports of stent migration after implantation |
| 2021-03-16 | Medtronic Inc. | Incorrect size printed on the device; packaging is labeled correctly. |
| 2020-12-14 | Bard Peripheral Vascular Inc | Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. |
| 2020-12-14 | Bard Peripheral Vascular Inc | Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. |
| 2020-12-14 | Bard Peripheral Vascular Inc | Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.