Medtronic Recalls VCLAS Laser Applicators Due to Saline Leakage Testing Defect
Medtronic is recalling 423 VCLAS laser applicator systems because they were not appropriately tested for saline leakage during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a manufacturing testing defect (saline leakage) in a medical device, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medtronic Navigation, Inc. is recalling 423 units of the VCLAS (Visualase Cooled Laser Ablation System) laser applicators. The affected devices include the 3mm, 10mm, and 15mm tip systems, identified by specific part numbers and lot codes listed in the recall notice. These devices were distributed nationwide in the United States.
The recall was initiated because the devices were not appropriately tested for saline leakage during the manufacturing process. This defect could potentially affect the performance or safety of the laser ablation system during use.
Healthcare facilities and consumers who possess these specific devices should stop using them and contact Medtronic Navigation, Inc. for further instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 423
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)
- 000212823919
- 000212894256
- 000212978141
- 000212783784
- 000212854585
- 000212926008
- 000212996201
- 000212823883
- 000212882619
- 000212956163
- 000213145362
- 000212656015
- 000212760821
- 000212913269
- 000212384009
- 000212660280
- 000212827856
- 000212922387
- 000212465594
- 000212664497
Distribution
Distributed nationwide across the United States.
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