Agency classClass IIOur severity:High FDA (Devices)·Z-1392-2019·Announced 2019-05-29

Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

Boston Scientific is recalling 27 Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause the device to stop emitting laser pulses during surgery.

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 involves a medical device used in surgical procedures where a failure to emit laser pulses could interrupt a procedure, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 27 units of the Auriga XL 4007 General System, identified by UPN M0068FS4007G0. These laser systems are intended for use in various surgical procedures, including open, laparoscopic, and endoscopic surgeries, to perform incision, excision, and other soft tissue treatments across multiple medical specialties.

The recall is due to a potential issue in the mechanical cooling system that may cause the consoles to exhibit faster than normal power degradation. This defect can lead to a low power error (1301) being displayed on the screen. When this error occurs, the console is designed to stop emitting laser pulses and enter a stand-by mode.

The affected units were distributed worldwide to 24 countries, including the United States, Australia, Brazil, Germany, and India. Specific serial numbers for the recalled units are listed in the official recall documentation. Healthcare facilities and users should stop using the affected units and contact Boston Scientific for further instructions.

The recalled product

Product: AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 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
Hazard: device-malfunction
surgical-interruption
Affected units: 27

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)

Serial Number: 21302771
21302815
21302786
21302800
21302843
21302928
21302842
21302915
21302900
21302933
21302783
21302922
21302934
21302935
21302942
21302956
21302957
21302989
21303002
21303000

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.

See all 9 products in this recall →

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