medical Class I Updated 2022-04-27

Medtronic Inc recalls Harmony Delivery Catheter System. Part of the Harmony Trans

Recalled Product

Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.


Hazard / Issue

There is potential for the capsule bond to break during the procedure.

Issued by

FDA

Distribution: Nationwide (United States)
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
View official government recall

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