—#156887

Product

Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K053087
Affected lot / code info: Lot Numbers: 211158059, 211560973, 211959879, 12473141, 212707035, 211158151, 211594328, 211977586, 212503634, 212745660, 211158152, 211599898, 211987873, 212504463, 212796559, 211181212, 211628257, 212127654, 212549456, 212912501, 211181547,211908695, 212141557, 212553428, 211184941, 211916062, 212148368, 212632884,211555011, 211926889, 212434500, 212647830, 211555017, 211950736, 212438405, 212701679

Why it was recalled

Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.

Root cause (FDA determination)

Component design/selection

Action the firm took

Medtronic sent an Urgent Medical Device Safety Alert dated June 1, 2017, to all affected customers. Actions to be taken: 1. Please examine your inventory and if any of the affected products listed above are found, immediately quarantine them for return to Medtronic. 2. Complete and follow instruction on the attached consignee response form. Sign and date the bottom of the form and then return the form to Medtronic at RS.NavFCAmedtronic.com or fax to Medtronic Technical Services at 651-367-7075. If you have affected products, contact Medtronic Technical Services at 1-800 595-9709 to receive a return material authorization (RMA) and arrange for their return and no charge replacements. Once an RMA number is obtained, ship the affected product to Medtronic. For further questions please call (720) 890-3241.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX

Timeline

Recall initiated: 2017-06-07
Posted by FDA: 2017-07-03
Terminated: 2018-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.