Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
Reported: August 2, 2023 Initiated: May 25, 2023 #Z-2232-2023
Product Description
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
Reason for Recall
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
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 205 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911. Recalled by Boston Scientific Corporation. Units affected: 205 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2232-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11