Recall Z-2755-2017 ยท GEX Powered Laser Surgical Instrument
Medtronic Navigation, Inc.
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
| Date | Jul 3, 2017 (initiated Jun 7, 2017) |
| Status | Terminated |
| Reason | 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 | Component design/selection |
| Action | 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 r |
| Quantity | 214 units |
| Distribution | US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM Biotex, Inc., Mar 1, 2006 |