Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Sep 25, 2024
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
FDA Devices Moderate Sep 25, 2024
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
FDA Devices Moderate Sep 25, 2024
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for…
FDA Devices Moderate Sep 25, 2024
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
FDA Devices Moderate Aug 7, 2024
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices ar…
FDA Devices Moderate Jul 24, 2024
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter
FDA Devices Critical May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
FDA Devices Moderate Apr 17, 2024
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who…
FDA Devices Moderate Apr 17, 2024
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients wh…
FDA Devices Moderate Apr 17, 2024
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who …
FDA Devices Critical Apr 3, 2024
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
FDA Devices Moderate Apr 3, 2024
OptiCross Coronary Imaging Catheter, REF H749518080120
FDA Devices Moderate Jan 17, 2024
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the f…
FDA Devices Moderate Nov 29, 2023