Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Mar 23, 2022
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
FDA Devices Moderate Mar 23, 2022
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
FDA Devices Moderate Mar 23, 2022
DREAMTOME 49-30MM/260CM Material Number: M00584010
FDA Devices Moderate Mar 23, 2022
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
FDA Devices Moderate Mar 23, 2022
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
FDA Devices Moderate Mar 23, 2022
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 44-30-260-035 Material Number: M00573060
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 39-30-450-025 Material Number: M00573110
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 44-30-450-035 Material Number: M00573070
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 44-20-450-035 Material Number: M00573050
FDA Devices Moderate Dec 22, 2021
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
FDA Devices Moderate Dec 8, 2021
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
FDA Devices Moderate Aug 25, 2021
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
FDA Devices Critical Jul 21, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Devices Critical Jul 21, 2021
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Devices Critical Jul 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Devices Moderate Jul 14, 2021
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Devices Moderate Jul 14, 2021
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
FDA Devices Moderate Jul 14, 2021
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
FDA Devices Critical May 26, 2021
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
FDA Devices Moderate May 5, 2021
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sac…
FDA Devices Moderate May 5, 2021
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulatio…
FDA Devices Low May 5, 2021
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN…
FDA Devices Moderate Apr 28, 2021
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 mai…
FDA Devices Moderate Apr 21, 2021
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with …
FDA Devices Moderate Mar 10, 2021
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561…
FDA Devices Moderate Mar 10, 2021
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M0056…
FDA Devices Moderate Mar 10, 2021
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; …
FDA Devices Critical Feb 17, 2021
EMBLEM S-ICD Model A209
FDA Devices Critical Feb 17, 2021
EMBLEM MRI S-ICD Model A219
FDA Devices Moderate Feb 3, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Devices Moderate Feb 3, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Devices Critical Jan 27, 2021
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, M…
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, M…
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Mad…
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Mad…
FDA Devices Moderate Jan 13, 2021
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation…
FDA Devices Moderate Jan 13, 2021
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 …
FDA Devices Moderate Jan 13, 2021
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation…
FDA Devices Moderate Dec 30, 2020
IceSeed" 1.5 Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020