Medtronic Recalls Visualase Cooled Laser Applicator Systems Due to Calibration Issues
Medtronic is recalling 1,283 Visualase Cooled Laser Applicator Systems because calibration errors may cause low laser energy output or fiber burnout.
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, and the hazard involves a risk of harm (low laser energy or burnout) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 1,283 units of the Visualase Cooled Laser Applicator System (VCLAS). The affected devices include the 3mm, 10mm, and 15mm tip versions, identified by specific part numbers and lot codes. The products were distributed nationwide in the United States and internationally to Israel.
The recall was initiated because certain lots of the laser diffusing fibers were not tested at intended laser power levels. This occurred due to an issue related to the calibration of the test equipment. As a result, there is a potential for low laser energy output from the fiber or fiber burnout at lower wattage.
The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue under magnetic resonance imaging (MRI) guidance in various medical and surgical specialties. Users should check their device part numbers and lot codes against the recall list provided by Medtronic and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator…
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Laser Therapy
- Affected units
- 1,283
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)
- a. Part Number 9735559
- UDI (00643169611986
- 00643169933361)
- Lot Codes (0212782059
- 0212894256
- 0213251294
- 0213331774
- 0213383266
- 0212783784
- 0212926008
- 0213259125
- 0213335148
- 0213383267
- 0212823883
- 0212956163
- 0213299882
- 0213375479
- 0213387215
- 0212823919
- 0212978141
Distribution
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