CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
Auriga 30 Laser System, Universal recalled by Boston Scientific
Boston Scientific is recalling Auriga 30 Laser System, Universal, distributed nationwide in the US. The recall was initiated on 22 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0897-2018
- FDA event ID
- 79096
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2017
- FDA classified
- 5 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 22 Sep 2017 | Recall initiated by company | |
| 5 Mar 2018 | Classified by FDA | +164 days |
| 14 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Where it was distributed
International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
Questions about this recall
Is Auriga 30 Laser System, Universal recalled?
Yes. Boston Scientific recalled Auriga 30 Laser System, Universal on 22 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0897-2018.
Why was it 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.
Which lots are affected?
Serial Number: 20413941, 20143944
Where was it sold?
International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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