FDA Device recall Z-2231-2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Singl…
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Singl… 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-2231-2023 |
| 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 ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
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: 08714729978671 Lot Numbers: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477 Exp. Date: 20-Oct-2025 to 10-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-2231-2023%22
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