LeMaitre Vascular, Inc. Recall: LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model
LeMaitre Vascular, Inc. Recall: LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: LeMaitre Vascular, Inc.; Product: LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitr
| Recalling firm | LeMaitre Vascular, Inc. |
|---|---|
| Product | 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 thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration. |
| 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, |
| Recall initiated | 20200323 |
| Recall number | Z-1567-2020 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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