Medtronic recalls specific NanoCross Elite PTA catheters with potential in-vivo balloon deflation issues. Affected units have unique reference numbers and serial codes. Contact Medtronic for details.
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Medtronic is recalling certain NanoCross Elite PTA catheters due to a risk of balloon deflation problems during medical procedures. This could lead to difficulty or inability to deflate the balloon in specific batches, potentially causing complications for patients.
The catheter's balloon may not deflate properly in certain batches, which could cause blockages or complications during medical procedures. This risk occurs when the balloon is inflated and needs to be deflated during treatment.
Patients undergoing vascular procedures who use the recalled catheters are affected. Medical professionals using these specific models for treatments are at risk of complications.
Check for reference numbers starting with AB14W050020090 through AB14W060200150 and specific serial numbers listed in the recall notice. The catheter size and length vary across the affected models.
Review the reference numbers and serial numbers listed in the recall notice to confirm if your catheter is affected.
The catheter's balloon may not deflate properly in certain batches, which could cause blockages or complications during medical procedures.
Check for reference numbers starting with AB14W050020090 through AB14W060200150 and specific serial numbers listed in the recall notice.
Contact Medtronic directly for guidance on next steps, as the recall notice does not specify a remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0904-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0904-2025 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.
