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.
Reported: April 8, 2020 Initiated: March 23, 2020 #Z-1567-2020
Product Description
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.
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 43315
- 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, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by LeMaitre Vascular, Inc.. Units affected: 43315.
Why was this product recalled? ▼
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Critical. Recall number: Z-1567-2020.
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