Boston Scientific Recalls Auriga XL 4007 Laser System for Cooling Defect
Boston Scientific is recalling specific Auriga XL 4007 laser systems due to a mechanical cooling issue that may cause premature power degradation and low power errors.
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 2/5 (Moderate).
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. The hazard involves a functional defect (power degradation) that triggers a safety mechanism (stand-by mode) to stop laser emission, representing a risk of harm or procedural interruption without reported injuries or fatalities.
Plain-English summary
Boston Scientific Corporation is recalling the Auriga XL 4007 Brazil System, Model M0068FS4007B0, with serial number 21302770. This medical device is intended for use in various surgical procedures, including urology, gastroenterology, and general surgery, to perform incision, excision, and coagulation of soft tissue.
The recall is due to a potential issue in the mechanical cooling system that may cause the console to exhibit faster than normal power degradation. This defect can lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enter a stand-by mode after this error message is displayed.
The affected unit was distributed worldwide to numerous countries, including Australia, Brazil, Germany, and the United States. Healthcare facilities and users should stop using the affected device and contact Boston Scientific Corporation for further instructions on the recall.
The recalled product
- Product
- AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- Affected units
- 1
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 (1)
- Serial Number: 21302770
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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