Boston Scientific Corporation
Fremont, CA
This page shows every FDA and USDA recall linked to Boston Scientific Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
35
Total Recalls
2000
First Recall
2017
Most Recent
AngioJet Ultra 5000 A Console:Foot Switch
Material number (U PN) 105650
Cardiovascular: The Console is a mult...
Jan 31, 2017
· Device
Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve.
The BSC Controller and Acce...
Jun 16, 2014
· Device
Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve.
The BSC Controller and Acces...
Jun 16, 2014
· Device
Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve.
The BSC Controller and Ac...
Jun 16, 2014
· Device
Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve.
The BSC Controller and...
Jun 16, 2014
· Device
Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve.
The BSC Controller and Ac...
Jun 16, 2014
· Device
Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve.
The BSC Controller and...
Jun 16, 2014
· Device
Terminated
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravas...
Apr 22, 2014
· Device
Terminated
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter:
Sterile, R; Sterilized using irradiation.
Product...
Jan 30, 2014
· Device
Terminated
Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip;
Boston Scientific Corporation: Made...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped;
Boston Scientific Corporation:...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped;
Boston Scientific Corporation:...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped;
Boston Scientific Corporation: Mad...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft.
Boston Scientific; Made in: 2405 West Orton C...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped;
Boston Scientific Corporation: Mad...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip;
Boston Scientific Corporation: Made in 2405 West O...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip;
Boston Scientific Corporation: Made in 2405 West O...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip;
Boston Scientific Corporation: Made...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft;
Boston Scientific Corporation: Made in 2405 W...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard;
Boston Scientific Corporation: Made in 24...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip;
Boston Scientific Corporation: Made...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip;
Boston Scientific Corporation: Made...
Jan 7, 2011
· Device
Terminated
Boston Scientific Guider Softip TM XF Guide Catheter
Catheter is intended to facilitate the placement of inter...
Jan 7, 2011
· Device
Terminated
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard;
Boston Scientific Corporation: Made in 24...
Jan 7, 2011
· Device
Terminated
Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA
Indicated f...
Dec 16, 2010
· Device
Terminated
Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremo...
Nov 26, 2010
· Device
Terminated
Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only;
Model Numbers: 18257, 1825...
Nov 15, 2010
· Device
Terminated
Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only;
Model Numbers: 182880US, 182...
Nov 15, 2010
· Device
Terminated
Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed b...
Nov 20, 2009
· Device
Terminated
Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number...
Sep 9, 2009
· Device
Terminated
Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston...
Jan 28, 2009
· Device
Terminated
Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasoun...
Dec 16, 2008
· Device
Terminated
Excelsior SL-10 Microcatheter, placed in sterile pouch. Manufactured by Boston Scientific Corporation, Fremon...
Oct 7, 2008
· Device
Terminated
iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremo...
Sep 23, 2008
· Device
Terminated
iReview" Software (Accessory To) iLab Ultrasound Imaging System,
Model Number: H74900018010, Catalog Number:...
Sep 17, 2008
· Device
Terminated