Boston Scientific Corporation: Medical Device Recalls in 2022
Updated on March 25, 2026.
According to to data from the FDA, there were 52 medical device recalls made by Boston Scientific Corporation in 2022. See the details of the recalls below.
You can see similar recalls for other firms.
Data Source: FDA.
- The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
- The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
- The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
- 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 radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
- SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
- Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
- JAGTOME RX 39-30-450-025 Material Number: M00573110
- 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 into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
- DREAMTOME 44-30MM/260CM Material Number: M00584050
- JAGTOME RX 39-30-260-025 Material Number: M00573100
- JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
- HYDRATOME RX 44-30MM/260CM Material Number: M00583050
- GreenLight HPSEA Laser Fibers, UPN 0010-2092
- EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
- HYDRATOME RX 44-20MM/450CM Material Number: M00583060
- DREAMTOME 49-20MM/260CM Material Number: M00584000
- RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
- JAGTOME RX 44-30-450-035 Material Number: M00573070
- JAGTOME RX 49-30-260-035 Material Number: M00573020
- 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 into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
- JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
- HYDRATOME RX 44-30MM/450CM Material Number: M00583070
- DREAMTOME 49-20MM/450CM Material Number: M00584020
- HYDRATOME RX 49-20MM/260CM Material Number: M00583000
- Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
- RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
- JAGTOME RX 44-20-450-035 Material Number: M00573050
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
- EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
- DREAMTOME 49-30MM/450CM Material Number: M00584030
- JAGTOME RX 44-30-260-035 Material Number: M00573060
- JAGTOME RX 44-20-260-035 Material Number: M00573040
- JAGTOME RX 39-30-260-025 Material Number: M00573100
- HYDRATOME RX 44-20MM/260CM Material Number: M00583040
- DREAMTOME 49-30MM/260CM Material Number: M00584010
- JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
- JAGTOME RX 39-20-260-025 Material Number: M00573080
- JAGTOME RX 39-20-450-025 Material Number: M00573090
- HYDRATOME RX 49-30MM/260CM Material Number: M00583010
- JAGTOME RX 49-30-450-035 Material Number: M00573030
- EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
- EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
- ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. UPN (1)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400
- JAGTOME RX 49-20-260-035 Material Number: M00573000
- EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
- DREAMTOME 44-30MM/450CM Material Number: M00584070
- Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
- ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as follows: UPN: (1)Twin Pack Box 1 M00519200 (2)Twin Pack Box 10 M00519201 (3)Single Pack Box 1 M00519220 (4)Single Pack Box 10 M00519221
- EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
- ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231
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