Reported Apr 27, 2022 · Ongoing
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation…
Medtronic Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc · 710 Medtronic Pkwy Mailstop Ls245 · Minneapolis, MN · 55432-5603
Is this the product you have?
- Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
- Lot codes and dates
- HARMONY-DCS (GTIN00763000341367)
- Lot Numbers0010519040, 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
- Amount recalled
- 1483 devices
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is potential for the capsule bond to break during the procedure.
Using this product could cause serious injury, illness or death — stop using it now.
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