Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Nov 29, 2023
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M005…
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
FDA Devices Moderate Aug 30, 2023
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
FDA Devices Moderate Aug 30, 2023
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to …
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to…
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN:…
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urologica…
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UP…
FDA Devices Moderate May 24, 2023
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
FDA Devices Moderate May 24, 2023
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
FDA Devices Moderate Apr 26, 2023
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or com…
FDA Devices Moderate Mar 15, 2023
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
FDA Devices Moderate Nov 9, 2022
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
FDA Devices Moderate Nov 9, 2022
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
FDA Devices Moderate Nov 9, 2022
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
FDA Devices Moderate Sep 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. Th…
FDA Devices Moderate Aug 31, 2022
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
FDA Devices Moderate Aug 10, 2022
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed i…
FDA Devices Moderate Aug 10, 2022
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed i…
FDA Devices Moderate May 25, 2022
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
FDA Devices Moderate May 25, 2022
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
FDA Devices Moderate May 25, 2022
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use wit…
FDA Devices Moderate May 4, 2022
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during rad…
FDA Devices Moderate May 4, 2022
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for p…
FDA Devices Moderate Apr 20, 2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
FDA Devices Moderate Apr 20, 2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
FDA Devices Moderate Mar 23, 2022
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 44-20-260-035 Material Number: M00573040
FDA Devices Moderate Mar 23, 2022
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
FDA Devices Moderate Mar 23, 2022
DREAMTOME 44-30MM/260CM Material Number: M00584050
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 39-30-260-025 Material Number: M00573100
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 39-20-450-025 Material Number: M00573090
FDA Devices Moderate Mar 23, 2022
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
FDA Devices Moderate Mar 23, 2022
DREAMTOME 49-20MM/260CM Material Number: M00584000
FDA Devices Moderate Mar 23, 2022
DREAMTOME 49-30MM/450CM Material Number: M00584030
FDA Devices Moderate Mar 23, 2022
JAGTOME RX 49-20-260-035 Material Number: M00573000
FDA Devices Moderate Mar 23, 2022
DREAMTOME 44-30MM/450CM Material Number: M00584070
FDA Devices Moderate Mar 23, 2022