Recall Z-0464-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-11-19, terminated 2024-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.. Reason: There have been reports of stent migration..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-19
- Terminated
- 2024-08-16
- Firm location
- Mounds View, MN, United States
Product description
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Reason for recall
There have been reports of stent migration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.