TufTex Embolectomy Catheter — Class II medical device recall Z-0228-2023
Ongoing recall by LeMaitre Vascular, Inc., reported 2022-11-23. Three lots tied by two trainees were released without performing the required pull test. If tied with inadequa
| Recall number | Z-0228-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2022-09-30 |
| Classified | 2022-11-11 |
| Reported by FDA | 2022-11-23 |
| Countries outside the US | AT, DE, FR, GB, IT, SE |
| Quantity | 72 |
| Reason classes | potency |
| Lot numbers | XSL0097, XSL0098, XSL0099 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0228-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.