Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Dec 30, 2020
Five IceSphere" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 i-Thaw" Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSeed" 1.5 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSeed" 1.5 MRI Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 CX 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 S 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 PLUS 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
Five IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSeed" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 MRI Cryoablation Needle¿
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX Prostate Cryoablation Kit
FDA Devices Moderate Dec 23, 2020
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultraso…
FDA Devices Moderate Nov 18, 2020
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
FDA Devices Moderate Nov 11, 2020
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
FDA Devices Moderate Nov 4, 2020
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch scree…
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
FDA Devices Moderate Aug 12, 2020
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexib…
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intend…
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablatio…
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended f…
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intende…
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for …
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intend…
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for c…
FDA Devices Moderate May 6, 2020
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemost…
FDA Devices Moderate May 6, 2020
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
FDA Devices Critical Apr 1, 2020
Imager II 5F Angiographic Catheters, 5 units per package.
FDA Devices Moderate Mar 25, 2020
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in h…
FDA Devices Moderate Dec 25, 2019
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650…
FDA Devices Moderate Dec 18, 2019
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of s…
FDA Devices Moderate Dec 18, 2019
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of s…
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
FDA Devices Moderate Dec 4, 2019
Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
FDA Devices Moderate Dec 4, 2019
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
FDA Devices Moderate Dec 4, 2019