Medtronic recalls Harmony Delivery Catheter System (HARMONY-DCS) due to potential capsule bond breaking during TPV valve replacement procedures. Affected lots listed in the recall notice.
There is potential for the capsule bond to break during the procedure.
Medtronic is recalling its Harmony Delivery Catheter System used in pulmonary valve replacements because the capsule bond might break during the procedure. This could lead to complications for patients undergoing the surgery.
The capsule bond in the catheter system could break during the procedure, potentially causing complications such as bleeding or other issues for patients receiving the valve replacement. This risk occurs during the surgical implantation process.
Patients undergoing pulmonary valve replacement surgery using the recalled Harmony Delivery Catheter System are most at risk. Healthcare providers using the system for implantation procedures may also be affected.
Check for the HARMONY-DCS (GTIN: 00763000341367) label on the catheter system. Affected lots include specific numbers listed in the recall notice, such as 0010519040 through 0010826593.
Look for the lot numbers listed in the recall notice (0010519040 through 0010826593) on the Harmony Delivery Catheter System.
This recall affects the Harmony Delivery Catheter System used in pulmonary valve replacement procedures. If you are scheduled for this surgery, your healthcare provider will inform you if the recalled system is being used.
The recall notice does not specify a remedy for the recalled product. Check with your healthcare provider or Medtronic for guidance.
Check the lot number on the Harmony Delivery Catheter System against the list of affected lots provided in the recall notice (0010519040 through 0010826593).
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0927-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0927-2022 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
