Boston Scientific Corporation: Medical Device Recalls in 2021
Updated on March 25, 2026.
According to to data from the FDA, there were 55 medical device recalls made by Boston Scientific Corporation in 2021. See the details of the recalls below.
You can see similar recalls for other firms.
Data Source: FDA.
- HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
- HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
- HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
- Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
- INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
- Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
- Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.
- Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.
- Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
- EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
- VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
- 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) K287 (added 7/15/2021)
- 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)
- INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
- EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
- Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
- INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
- 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)
- VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
- HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
- HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
- Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
- HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
- HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
- HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
- Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
- Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
- Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
- ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total lesion lengths up to 190 mm.
- UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.
- MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
- TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
- EMBLEM S-ICD Model A209
- Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- EMBLEM MRI S-ICD Model A219
- EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
- TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
- 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 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156
- VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
- MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
- EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
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