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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
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devi...
Medical Devices·3 affected·May 15, 2017
High RiskFDA
Boston Scientific Corporation
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral v...
Surgical Devices·137 affected·Apr 5, 2017
High RiskFDA
Boston Scientific Corporation
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that co...
Medical Devices·3,402 affected·Jan 31, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Medical Devices·4,500 affected·Jan 12, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001...
Surgical Devices·39 affected·Dec 15, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Surgical Devices·26 affected·Dec 13, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Medical Devices·15 affected·Nov 30, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H74914...
Medical Devices·47 affected·Mar 28, 2016
CriticalFDA
Boston Scientific Corporation
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the ...
Surgical Devices·21,155 affected·Mar 22, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is ...
Medical Implants·4 affected·Mar 18, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing ...
Cardiac Devices·5 affected·Dec 10, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114...
Medical Implants·900 affected·Nov 25, 2015
CriticalFDA
Boston Scientific Corporation
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H80...
Medical Devices·955 affected·Oct 9, 2015
CriticalFDA
Boston Scientific Corporation
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), ...
Medical Devices·955 affected·Oct 9, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Cardiac Devices·3 affected·Sep 17, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M63...
Cardiac Devices·29,169 affected·Aug 25, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU...
Cardiac Devices·29,169 affected·Aug 25, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Boston Scientific Corporation
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the ampl...
Medical Devices·43 affected·Jun 2, 2015
High RiskFDA
Boston Scientific Corporation
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extra...
Surgical Devices·39 affected·Apr 27, 2015
High RiskFDA
Boston Scientific Corporation
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Surgical Devices·289 affected·Feb 25, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage ...
Surgical Devices·918 affected·Feb 25, 2015
High RiskFDA
Boston Scientific Corporation
StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
Medical Devices·7 affected·Sep 30, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated f...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated f...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Medical Devices·9 affected·Apr 3, 2014
High RiskFDA
Boston Scientific Corporation
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Surgical Devices·7 affected·Mar 3, 2014
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Ballo...
Surgical Devices·39 affected·Dec 18, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
Surgical Devices·34 affected·Dec 18, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Surgical Devices·38 affected·Dec 18, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Bosto...
Medical Devices·253 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device...
Medical Devices·3,300 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Bosto...
Medical Devices·425 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Bost...
Medical Devices·0 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston...
Medical Devices·740 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in...
Medical Devices·449 affected·Nov 5, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are ind...
Surgical Devices·1,331 affected·Jul 31, 2013
RecallFDA
Boston Scientific Corporation
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation ...
Medical Devices·91 affected·May 28, 2013
High RiskFDA
Boston Scientific Corporation
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequenc...
Surgical Devices·19,716 affected·Sep 17, 2012
High RiskFDA
Boston Scientific Corporation
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable,...
Surgical Devices·19 affected·Sep 17, 2012
High RiskFDA
Boston Scientific Corporation
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Po...
Medical Devices·1,970 affected·May 16, 2012
High RiskFDA
Boston Scientific Corporation
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile P...
Medical Devices·2,760 affected·May 16, 2012
High RiskFDA
Boston Scientific Corporation
Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Po...
Medical Devices·1,340 affected·May 16, 2012