Medtronic recalls Harmony Delivery Catheter Systems with specific lot numbers due to potential distal tip detachment during procedures. Affected units may require replacement to prevent complications.
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Medtronic is recalling certain Harmony Delivery Catheter Systems that could detach at the tip during medical procedures. This risk might cause complications if the catheter becomes dislodged during use.
The catheter's inner shaft assembly may detach from the delivery system under specific medical conditions or during procedures. This detachment could lead to complications if the catheter becomes dislodged during treatment.
Patients undergoing cardiac procedures who use the recalled catheter systems are most at risk. Healthcare providers using these devices in medical settings may also be affected.
Check for the GTIN numbers 00763000341367, 00763000544027, 00763000520151, or 00763000582951 on the product packaging. Also look for the listed lot numbers in the recall notice.
Verify the GTIN and lot numbers on your catheter system to determine if it is affected by this recall.
Reach out to Medtronic Heart Valves Division for guidance on next steps if your device is affected.
The recall is due to a manufacturing issue that may cause the distal tip of the catheter to detach during procedures under certain anatomical or procedural conditions.
Check the GTIN and lot numbers on your device to see if it is affected. Contact Medtronic Heart Valves Division for specific instructions.
The recall indicates a potential risk of tip detachment during procedures, which could lead to complications. However, the remedy does not specify immediate action to stop use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2624-2026 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2624-2026 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.
