Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapoli
FDA device recall Z-1521-2011 · posted 2011-03-03 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- Reason for recall
- Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896. Recently it was reported that the endovenous laser fiber cage and guidewire tip of the WireFiber became separated. It is possible that separation could occur during patient procedure and has the p
- Action taken
- Vascular Solutions sent an "Urgent Medical Device Recall" letter dated January 10, 2011. The letter described the issue and the product affected. Advised consignees to immediately check their inventory , place affected product in a secure location, and to complete and return the Customer Inventory Form. For questions regarding this recall call 763-656-4210.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 41
- Distribution
- Nationwide Distribution - USA including CT, MA, MN, NY, VA
- Date initiated
- 2011-01-10
- Date posted
- 2011-03-03
- Date terminated
- 2012-05-03
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARI-LASE WIRE FIBER (K072332) | Vascular Solutions, Inc. | 2008-01-10 |