Boston Scientific recalls
Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
FDA Device · Class II · 2021-08-25 · Boston Scientific - TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA Device · Class II · 2021-08-25 · Boston Scientific - ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Device · Class I · 2021-07-21 · Boston Scientific - INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Device · Class I · 2021-07-21 · Boston Scientific - 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 Device · Class I · 2021-07-21 · Boston Scientific - INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Device · Class I · 2021-07-21 · Boston Scientific - VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f)…
FDA Device · Class I · 2021-07-21 · Boston Scientific - INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Device · Class I · 2021-07-21 · Boston Scientific - Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Device · Class II · 2021-07-14 · Boston Scientific - Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
FDA Device · Class II · 2021-07-14 · Boston Scientific - VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
FDA Device · Class II · 2021-07-14 · Boston Scientific - VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Device · Class II · 2021-07-14 · Boston Scientific - Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
FDA Device · Class II · 2021-07-14 · Boston Scientific - Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
FDA Device · Class II · 2021-07-14 · Boston Scientific - VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of sympt…
FDA Device · Class I · 2021-05-26 · Boston Scientific - ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo…
FDA Device · Class II · 2021-05-26 · Boston Scientific - VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature
FDA Device · Class I · 2021-05-26 · Boston Scientific - UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposusp…
FDA Device · Class II · 2021-05-05 · Boston Scientific - Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and m…
FDA Device · Class II · 2021-05-05 · Boston Scientific - EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observ…
FDA Device · Class III · 2021-05-05 · Boston Scientific - The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline
FDA Device · Class II · 2021-04-28 · Boston Scientific - MAMBA Microcatheter
FDA Device · Class II · 2021-04-21 · Boston Scientific - MAMBA Flex 135 Microcatheter
FDA Device · Class II · 2021-04-21 · Boston Scientific - Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
FDA Device · Class II · 2021-03-10 · Boston Scientific - Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310
FDA Device · Class II · 2021-03-10 · Boston Scientific - Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190
FDA Device · Class II · 2021-03-10 · Boston Scientific - EMBLEM S-ICD Model A209
FDA Device · Class I · 2021-02-17 · Boston Scientific - EMBLEM MRI S-ICD Model A219
FDA Device · Class I · 2021-02-17 · Boston Scientific - EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System
FDA Device · Class II · 2021-02-03 · Boston Scientific - EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System
FDA Device · Class II · 2021-02-03 · Boston Scientific - EMBLEM S-ICD Subcutaneous Electrode Model 3501
FDA Device · Class I · 2021-01-27 · Boston Scientific - ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary ven…
FDA Device · Class II · 2021-01-27 · Boston Scientific - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 0871472…
FDA Device · Class I · 2021-01-20 · Boston Scientific - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 0871472…
FDA Device · Class I · 2021-01-20 · Boston Scientific - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 087147299…
FDA Device · Class I · 2021-01-20 · Boston Scientific - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 087147299…
FDA Device · Class I · 2021-01-20 · Boston Scientific - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 087147299…
FDA Device · Class I · 2021-01-20 · Boston Scientific - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 0871472…
FDA Device · Class I · 2021-01-20 · Boston Scientific - AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation…
FDA Device · Class II · 2021-01-13 · Boston Scientific - AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation…
FDA Device · Class II · 2021-01-13 · Boston Scientific - AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for im…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for im…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for im…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
FDA Device · Class II · 2021-01-06 · Boston Scientific - Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
FDA Device · Class II · 2021-01-06 · Boston Scientific - IceSeed" 1.5 Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceSphere" 1.5 CX 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceSphere" 1.5 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific