Medtronic Inc Recall 89754
Description: Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Medtronic Inc Recall 89754 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0927-2022 |
| Event ID | 89754 |
| Event Description | Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System. |
| Product Type | Devices |
| Distribution | US Nationwide and the countries of Canada. |
| Quantity | 1483 devices |
| Recall Reason | There is potential for the capsule bond to break during the procedure. |
| Device Classification | 20220427 |
| Device Code Info | HARMONY-DCS (GTIN: 00763000341367); Lot Numbers: 0010519040, 0010565921, 0010578123, 0010578126, 0010583884, 0010631963, 0010631969, 0010631971, 0010717000, 0010717001, 0010717002, 0010723188, 0010723189, 0010723190, 0010727345, 0010804938, 0010826589, (the following lots were added 4/22/2022) 0010826591, 0010826592, and 0010826593 |
| Center Classification Date | 20220418 |
| Recall Initiation Date | 20220302 |
| Recalling Firm | Medtronic Inc |
| Initial Notification | Letter |
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