Z-0898-2018Class II

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

Name: Z-0898-2018 Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures
Creator: Boston Scientific Corporation
Published: 2017-09-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-09-22 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures on 2017-09-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0898-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-22
Posted: 2018-03-05
Terminated: 2018-08-14
Recalling firm: Boston Scientific Corporation
Product: Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 9
Distribution: International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
Product codes and lots: Serial Number: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0898-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0897-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05
Z-0898-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05

Product code GEX

K111475Class IIAuriga XlStarmedtec GmbH / cleared 2011-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)