Z-0927-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- March 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1483 devices
Product Description
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Reason for Recall
There is potential for the capsule bond to break during the procedure.
Distribution Pattern
US Nationwide and the countries of Canada.
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