Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic
FDA device recall Z-1880-2019 · posted 2019-06-26 · Terminated
Recall details
- Recalling firm
- Medtronic Inc
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DYE
- Quantity affected
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
- Date initiated
- 2019-05-21
- Date posted
- 2019-06-26
- Date terminated
- 2020-10-07
- Location
- Minneapolis, MN
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