Agency classClass IIOur severity:High FDA (Devices)·Z-0025-2018·Announced 2017-10-25

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Category: Medical Device — Surgical / Laser
Hazard: manufacturing-defect
saline-leakage
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.

Same manufacturer · Medtronic Navigation, Inc.

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