Medtronic Inc Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Brand
Medtronic Inc
Lot Codes / Batch Numbers
GTIN: 00643169594852 Serial Number: B743335
Products Sold
GTIN: 00643169594852 Serial Number: B743335
Medtronic Inc is recalling Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native o due to Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026