Recall archive / FDA device enforcement
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted... — FDA record Z-0228-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 30, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
- Reason
- Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
- Classification
- Class II
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 72 (OUS only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0228-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lots XSL0097, XSL0098, and XSL0099 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 23, 2022
- Recall initiation date
- Sep 30, 2022
- Center classification date
- Nov 11, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.