Drug recall
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is…
FDA recall event 91006 · Class II · LeMaitre Vascular, Inc.
Key facts
| Event ID | 91006 |
|---|---|
| Recall numbers | Z-0228-2023 |
| Recalling firm | LeMaitre Vascular, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 30, 2022 |
| Report date | Nov 23, 2022 |
| City | Burlington |
| State | MA |
| Country | United States |
| FEI number | 1220948 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: