Boston Scientific Corporation
245 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Boston Scientific Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-08-02FDA-DeviceClass IIFlexiva 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 Single-pack UPN : M006L8405960
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
- 2023-08-02FDA-DeviceClass IIFlexiva 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
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
- 2023-05-24FDA-DeviceClass IIWATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- 2023-05-24FDA-DeviceClass IIWATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- 2023-04-26FDA-DeviceClass IIHabib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").
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