LeMaitre TufTex Catheter Recall: Risk of Balloon Failure During Use
LeMaitre Vascular recalls 54 units of TufTex Over-the-Wire Embolectomy Catheter (Catalog E1651-88) due to potential balloon failure during medical procedures. Affected units distributed nationwide in specific states.
Use caution until it’s fixed
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
What happened, in plain English
LeMaitre Vascular is recalling 54 units of TufTex Over-the-Wire Embolectomy Catheter because the device may fail under pull force during medical procedures. This could lead to complications if the catheter balloon breaks during use. Read more at govinfonow.com/recall/1629470-lemaitre-vascular-inc-recalls-tuftex-over-the-wire-embolectomy-catheter.
Source Summary by GovInfoNow · govinfonow.com/recall/1629470-lemaitre-vascular-inc-recalls-tuftex-over-the-wire-embolectomy-catheter · Updated October 21, 2026 · FDA enforcement record: FDA #Z-0117-2027
Cite this page
“LeMaitre TufTex Catheter Recall: Risk of Balloon Failure During Use.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629470-lemaitre-vascular-inc-recalls-tuftex-over-the-wire-embolectomy-catheter. Based on FDA recall #Z-0117-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2027%22&limit=1).
Why it’s dangerous
The catheter's balloon components can fail under pull force during medical procedures, potentially causing complications. This failure occurs due to insufficient strength in the device's design during testing.
Who’s affected
Healthcare professionals using the TufTex catheter in medical procedures are most at risk. Patients receiving these procedures may also be affected if the catheter fails.
How to tell if you have this one
Check for the catalog number E1651-88 on the device. The lot number XOT00002181 is associated with this recall. The device was distributed nationwide in specific states including California, Florida, Georgia, Kentucky, Louisiana, New Jersey, Ohio, Pennsylvania, and South Carolina.
- Brand
LeMaitre Vascular- Category
Medical device
What to do — step by step
Check Device Details
Look for the catalog number E1651-88 and lot number XOT00002181 on the catheter.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Kentucky, Louisiana, New Jersey, Ohio, Pennsylvania, South Carolina.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
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-0117-2027 (August 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0117-2027 to see it in context.
- Plain-language summary written by qwen3:4b on October 21, 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.