Z-2755-2017 Class II Terminated
FDA device recall Z-2755-2017 was initiated by Medtronic Navigation, Inc. on June 7, 2017 and is designated Class II. Reason for recall: 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 thr… The recall status is terminated (terminated June 29, 2018). Affected quantity: 214 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- June 7, 2017
- Termination Date
- June 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 214 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX
Code Information
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