# Class II recall Z-0117-2027: LeMaitre Vascular, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0117-2027 |
| Recalling firm | LeMaitre Vascular, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | TufTex¿ Over-the-Wire Embolectomy Catheter;  Catalog Number: E1651-88; |
| Reason | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. |
| Quantity | 54 |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC. |
| Recall initiated | 2026-08-28 |
| Reported | 2026-10-14 |
| Firm location | Burlington, MA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.