Medtronic Navigation, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2755-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 7, 2017

Date Posted: August 2, 2017

Recall Number: Z-2755-2017

Event ID: 77623

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.

Status: Terminated

Product Quantity: 214 units

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated