Official recall record
SOLTIVE™ Premium SuperPulsed TF Laser System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
As part of Olympus' post market surveillance of SOLTIVE™ laser use, including a review of customer complaints and adverse events, we have become aware that some clinicians are defaulting to the preset laser values for all clinical procedures when that is not consistent with the instructions for use. Olympus is reminding users that preset treatment parameters may not be appropriate for all patients and are guidelines only. Olympus is sending this reminder after reviewing twenty-eight (28) complaints reported between 2021 to 2023 related to ureteral stone procedures, that described serious injuries. Recall start date: February 5, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.