Medtronic Visualase Cooled Laser Applicator System Recalled for Seal Defect
Medtronic is recalling 214 units of the Visualase Cooled Laser Applicator System because the cap may fail to seal, causing saline leaks.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (leaking) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 214 units of the Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561. The product includes a laser diffusing fiber, cooling catheter, pump tubing set, and drainage bag. The recall covers units distributed to the states of California, Georgia, Minnesota, Florida, New York, Illinois, and Texas.
The recall is due to a defect in the VCLAS 15MM TIP cap, also known as the Tuohy Borst Adapter (TBA). The cap may not be capable of creating a seal around the optical fiber. This failure can result in low retention force to the optical fiber, causing saline to leak out of the TBA and potentially compromising the cooling system's function.
Healthcare providers and facilities that have received these specific lot numbers should stop using the affected devices and contact Medtronic for instructions on return or replacement. The agency has classified this as a Class II recall.
The recalled product
- 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
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 214
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 211158059
- 211560973
- 211959879
- 12473141
- 212707035
- 211158151
- 211594328
- 211977586
- 212503634
- 212745660
- 211158152
- 211599898
- 211987873
- 212504463
- 212796559
- 211181212
- 211628257
- 212127654
- 212549456
- 212912501
Distribution
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