Recall Z-0927-2022 ยท NPV Pulmonary Valve Prosthesis Percutaneously Delivered
Medtronic Inc
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
| Date | Apr 18, 2022 (initiated Mar 2, 2022) |
| Status | Open, Classified |
| Reason | There is potential for the capsule bond to break during the procedure. |
| Root cause | Under Investigation by firm |
| Action | Beginning 02-MAR-2022 Medtronic initiated communications of an Urgent Medical Device Notice letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Notice notification and follow the Recommended Actions. Implanting physicians associated with related valves to the Harmony DCS were included in notifications, though these valve products are not subject to the recall issue. Additional verbal communication was initiated for a full product recall on March 24. Written communicati |
| Quantity | 1483 devices |
| Distribution | US Nationwide and the countries of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.