Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures. |
| Quantity | 2 |
| Distribution | International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania. |
| Initiated | 2017-09-22 |
| Classified | 2018-03-05 |
| Terminated | 2018-08-14 |
| Recall number | Z-0897-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-0897-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79096/
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