Recall Z-1884-2019— Medtronic Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc, initiated 2019-05-21, terminated 2020-10-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.. Reason: Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels..
- Recalling firm
- Medtronic Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-21
- Terminated
- 2020-10-07
- Firm location
- Minneapolis, MN, United States
Product description
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Reason for recall
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.