—#161329

Product

Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111475
Affected lot / code info: Serial Number: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.

Why it was recalled

Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.

Root cause (FDA determination)

Process design

Action the firm took

Urgent Medical Device Field Correction letters, dated September 2017, were sent to distributors and medical facilities with instructions for acknowledging the notice and making corrections. The letter identified the affected device and the reason for the correction. Customers were to check their inventory, segregate, and cease distribution for the affected devices. Customers were to complete and return the acknowledgment form. **NO PRODUCT IS BEING RECALLED AND YOU ARE NOT REQUIRED TO RETURN PRODUCT TO BOSTON SCIENTIFIC**

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.

Timeline

Recall initiated: 2017-09-22
Posted by FDA: 2018-03-05
Terminated: 2018-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161329. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.