Z-1521-2011

Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court...

Name: Z-1521-2011 Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court...
Creator: Vascular Solutions, Inc.
Published: 2011-01-10
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2011-01-10 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369 The VARI-LASE WireFiber is... on 2011-01-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1521-2011
Status: Terminated
Initiated: 2011-01-10
Posted: 2011-03-03
Terminated: 2012-05-03
Recalling firm: Vascular Solutions LLC
Product: Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369 The VARI-LASE WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Product code: GEX Powered Laser Surgical Instrument
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 41
Distribution: Nationwide Distribution - USA including CT, MA, MN, NY, VA
Product codes and lots: Lot #'s 550896 and 550898

Product code GEX

K072332Class IIVari-Lase Wire FiberVascular Solutions, Inc. / cleared 2008-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)