FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
- Recall number
- Z-0897-2018
- Recalling firm
- Boston Scientific Corporation
- Product
- Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
- Status
- Terminated
- Initiated
- 2017-09-22
- Posted
- 2018-03-05
- Terminated
- 2018-08-14
- Reason
- 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
- Process design
- Action
- 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**
- Quantity
- 2
- Distribution
- International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
- Lot, serial or model codes
- Serial Number: 20413941, 20143944
- 510(k) numbers
- ["K111475"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28