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Boston Scientific Corporation Recalls

383 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Boston Scientific Corporation.

383Total Recalls
91Critical
8.6MUnits Affected
Mar 30, 2026Most Recent
All Recalls

Every Boston Scientific Corporation Recall

Sorted by most recent. Click any recall for full details.

383 recalls
High RiskFDA
Boston Scientific Corporation
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
Medical Devices·261 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceRod" 1.5 MRI Cryoablation Needle¿
Medical Devices·772 affected·Nov 18, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714...
Medical Implants·219 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714...
Medical Implants·319 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714...
Medical Implants·302 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 0871472...
Medical Implants·386 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 0871472...
Medical Implants·278 affected·Nov 17, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Medical Implants·47,000 affected·Nov 13, 2020
High RiskFDA
Boston Scientific Corporation
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter...
Surgical Devices·90 affected·Nov 3, 2020
High RiskFDA
Boston Scientific Corporation
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Pros...
Medical Implants·24,064 affected·Sep 24, 2020
High RiskFDA
Boston Scientific Corporation
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Medical Devices·8 affected·Sep 22, 2020
High RiskFDA
Boston Scientific Corporation
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a...
Medical Devices·1 affected·Sep 22, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needle...
Surgical Devices·193 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX...
Surgical Devices·88 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles ar...
Surgical Devices·48 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles...
Surgical Devices·18,440 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are i...
Surgical Devices·656 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needle...
Surgical Devices·79 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are in...
Surgical Devices·7,536 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, abla...
Surgical Devices·146,633 affected·Mar 30, 2020
High RiskFDA
Boston Scientific Corporation
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended ...
Medical Implants·4 affected·Feb 12, 2020
CriticalFDA
Boston Scientific Corporation
Imager II 5F Angiographic Catheters, 5 units per package.
Surgical Devices·1,068,827 affected·Feb 11, 2020
High RiskFDA
Boston Scientific Corporation
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and a...
Medical Devices·139 affected·Nov 18, 2019
High RiskFDA
Boston Scientific Corporation
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and a...
Medical Devices·179 affected·Nov 18, 2019
High RiskFDA
Boston Scientific Corporation
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-...
Surgical Devices·169 affected·Nov 8, 2019
High RiskFDA
Boston Scientific Corporation
NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7...
Surgical Devices·14,145 affected·Oct 24, 2019
High RiskFDA
Boston Scientific Corporation
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H749393351...
Surgical Devices·14,145 affected·Oct 24, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
Medical Implants·271 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
Medical Implants·542 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
Medical Implants·651 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
Medical Implants·66 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
Medical Implants·222 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
Medical Implants·179 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
Medical Implants·66 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
Medical Implants·109 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
Medical Implants·35 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
Medical Implants·139 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
Medical Implants·54 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
Medical Implants·940 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Medical Devices·150 affected·Sep 18, 2019
High RiskFDA
Boston Scientific Corporation
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Medical Implants·404 affected·Aug 21, 2019
High RiskFDA
Boston Scientific Corporation
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Medical Implants·28 affected·Aug 21, 2019
High RiskFDA
Boston Scientific Corporation
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Medical Devices·1 affected·Jul 19, 2019