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.
- 2024-09-25FDA-DeviceClass IIFlexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- 2024-09-25FDA-DeviceClass IIFlexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- 2024-09-25FDA-DeviceClass IIFlexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- 2024-08-07FDA-DeviceClass IICapio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
- 2024-08-07FDA-DeviceClass IICapio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
- 2024-07-24FDA-DeviceClass IIAutotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
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