Edwards Fogarty Catheter Recall: Slow Balloon Deflation Risk
Edwards Lifesciences recalls Fogarty Thru-Lumen Embolectomy Catheters with REF 12TLW805F35 due to potential slow balloon deflation (over 15 seconds) during use.
Use caution until it’s fixed
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Contact the company
What happened, in plain English
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters with specific reference number 12TLW805F35 because they may deflate slower than normal, taking longer than 15 seconds. This could lead to complications during medical procedures if not addressed promptly. Read more at govinfonow.com/recall/57360-edwards-fogarty-catheter-recall-slow-balloon-deflation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/57360-edwards-fogarty-catheter-recall-slow-balloon-deflation-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0238-2024
Cite this page
“Edwards Fogarty Catheter Recall: Slow Balloon Deflation Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57360-edwards-fogarty-catheter-recall-slow-balloon-deflation-risk. Based on FDA recall #Z-0238-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0238-2024%22&limit=1).
Why it’s dangerous
The catheter's balloon may take longer than 15 seconds to deflate, which can cause blockages or complications during medical procedures. This delay could interfere with the catheter's intended function in removing blood clots.
Who’s affected
Healthcare professionals using the catheter for embolectomy procedures are most at risk. Patients receiving this device during medical treatment may also be affected.
How to tell if you have this one
Check for the reference number 12TLW805F35 on the catheter packaging or label. The catheter also has a unique identifier (UDI-DI: 00690103043532) and lot number 64936927.
- Brand
Edwards Lifesciences- Category
Medical device
What to do — step by step
Check Product Details
Look for the reference number 12TLW805F35 on the catheter or packaging.
How this recall unfolded
Recall timeline
FDA published this recall 2 months 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-0238-2024 (September 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0238-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.