Drug recall
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The…
FDA recall event 85193 · Class I · LeMaitre Vascular, Inc.
Key facts
| Event ID | 85193 |
|---|---|
| Recall numbers | Z-1567-2020 |
| Recalling firm | LeMaitre Vascular, Inc. |
| Product type | Devices |
| Products | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. |
| Initiation date | Mar 23, 2020 |
| Report date | Apr 8, 2020 |
| 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: