Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Check against the official notice below — it lists the full affected range.
Medtronic Inc. is recalling 1,483 units of the Harmony Delivery Catheter System, which is part of the Harmony Transcatheter Pulmonary Valve Replacement Implantation System. The recall affects devices distributed nationwide in the United States and in Canada. The recalled devices are identified by the GTIN 00763000341367 and include 19 specific lot numbers ranging from 0010519040 through 0010826593. The reason for the recall is that the capsule bond may break during the medical procedure.
The source document does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for the capsule bond to break during the procedure.
Reason for recall: There is potential for the capsule bond to break during the procedure. Distribution: US Nationwide and the countries of Canada. Quantity: 1483 devices Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.