Device product
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Z-0927-2022
Product summary
- Firm
- Medtronic Inc
- Event
- Event 89754
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1483 devices
- Official record key
device-enforcement:Z-0927-2022
Official wording
Reason: There is potential for the capsule bond to break during the procedure.
Code information: 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
Distribution pattern: US Nationwide and the countries of Canada.
Derived failure modes
-
Unknown
There is potential for the capsule bond to break during the procedure.