TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted us
FDA device recall Z-0228-2023 · posted 2022-11-11 · Open, Classified
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- 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.
- Action taken
- On September 30, 2022, the recalling firm notified affected customers via Urgent Field Safety Notice letters. Users were instructed to immediately identify, quarantine, and return the affected devices.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- DXE
- Quantity affected
- 72 (OUS only)
- Distribution
- No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
- Date initiated
- 2022-09-30
- Date posted
- 2022-11-11
- Location
- Burlington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEMAITRE EMBOLECTOMY CATHETER (K992368) | Vascutech, Inc. | 1999-12-09 |