Recalls / —
—#173391
Product
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- FDA product code
- DYE — Replacement Heart-Valve
- Device class
- Class 3
- Medical specialty
- Cardiovascular
- PMA numbers
- P980043
- Affected lot / code info
- GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146
Why it was recalled
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.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
The firm initiated the recall by telephone on 05/21/2019 and followed with a letter disseminated on 06/05/2019 which requested that the consignee quarantine any unused affected product and return it to Medtronic.
Recalling firm
- Firm
- Medtronic Inc
- Address
- 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, Minnesota 55432-5603
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
Timeline
- Recall initiated
- 2019-05-21
- Posted by FDA
- 2019-06-26
- Terminated
- 2020-10-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.