Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation
Boston Scientific is recalling 18 Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal 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 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 with a functional defect that could lead to unexpected cessation of laser pulses during a procedure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 18 units of the Auriga 30 General System (UPN: M0068S30G0). These laser systems are intended for use in various surgical procedures, including open, laparoscopic, and endoscopic surgeries, to perform incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue.
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 issue 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 Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates, and Vietnam. Specific serial numbers for the 18 affected units are listed in the official recall documentation. Healthcare facilities should stop using these specific units and contact Boston Scientific for instructions on the next steps.
The recalled product
- Product
- AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 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 incision…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Laser System
- Affected units
- 18
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 (18)
- Serial Number: 21302793
- 21302835
- 21302799
- 21302844
- 21302861
- 21302780
- 21302921
- 21302999
- 21303007
- 21303013
- 21303012
- 21303064
- 21303032
- 21303033
- 21303045
- 21303065
- 21302816
- 21302994
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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