FDA Device recall Z-2228-2023
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to…
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to… by Boston Scientific, citing manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Conti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2228-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-25 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
Reason
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Identifiers
| code_info | GTIN: 08714729978572 Lot Number: 30554442 Exp. Date: 16-Nov-2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2023%22
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