Boston Scientific Corporation Recall 92570
Description: Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
Boston Scientific Corporation Recall 92570 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2230-2023 |
| Event ID | 92570 |
| Event Description | Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Quantity | 1245 units |
| Recall 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 |
| Device Classification | 20230802 |
| Device Code Info | GTIN: 08714729978664 Lot Numbers: 2030305543, 30305544, 30305545, 30305546, 30305547, 30305548, 30305549, 30389370, 30389371, 30389372, 30389373, 30389375, 30389376, 30389377, 30389378, 30429835, 30429837, 30479586, 30479587, 30479589, 30479590, 30521464, 30521466, 30521467, 30521468, 30554456, 30554457. Exp. Date: 7-Oct-2025 to 16-Nov-2025 |
| Center Classification Date | 20230721 |
| Recall Initiation Date | 20230525 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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