Medtronic NanoCross Elite PTA Catheter Recall: Balloon Deflation Risk
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.
Use caution until it’s fixed
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/53319-medtronic-nanocross-elite-pta-catheter-recall-balloon-deflation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53319-medtronic-nanocross-elite-pta-catheter-recall-balloon-deflation-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0904-2025
Cite this page
“Medtronic NanoCross Elite PTA Catheter Recall: Balloon Deflation Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53319-medtronic-nanocross-elite-pta-catheter-recall-balloon-deflation-risk. Based on FDA recall #Z-0904-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0904-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Patients undergoing vascular procedures who use the recalled catheters are affected. Medical professionals using these specific models for treatments are at risk of complications.
How to tell if you have this one
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.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Product Details
Review the reference numbers and serial numbers listed in the recall notice to confirm if your catheter is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0904-2025 (December 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0904-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.