Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Jan 24, 2018
ALTRUA 2 SR Pacemaker
FDA Devices Moderate Jan 24, 2018
ESSENTIO MRI SR Pacemaker
FDA Devices Moderate Jan 24, 2018
ESSENTIO MRI EL DR Pacemaker
FDA Devices Moderate Jan 24, 2018
ACCOLADE EL DR Pacemaker
FDA Devices Moderate Nov 15, 2017
RESONATE X4 CRT-D, Model G447, Sterile.
FDA Devices Moderate Nov 15, 2017
RESONATE EL ICD VR, Model D432, Sterile.
FDA Devices Moderate Nov 15, 2017
MOMENTUM X4 CRT-D, Model G138, Sterile.
FDA Devices Moderate Nov 15, 2017
RESONATE EL ICD DR, Model D433, Sterile.
FDA Devices Moderate Nov 15, 2017
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure …
FDA Devices Moderate Sep 20, 2017
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pre…
FDA Devices Moderate Aug 23, 2017
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threaten…
FDA Devices Moderate Aug 23, 2017
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide d…
FDA Devices Moderate Aug 23, 2017
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defib…
FDA Devices Moderate Jul 12, 2017
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pa…
FDA Devices Moderate Jul 12, 2017
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
FDA Devices Moderate May 10, 2017
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. …
FDA Devices Moderate Apr 19, 2017
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
FDA Devices Moderate Mar 15, 2017
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the T…
FDA Devices Moderate Feb 15, 2017
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
FDA Devices Moderate Jan 11, 2017
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
FDA Devices Moderate May 4, 2016
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanentl…
FDA Devices Critical Apr 27, 2016
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of f…
FDA Devices Moderate Apr 20, 2016
Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UP…
FDA Devices Moderate Jan 20, 2016
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as n…
FDA Devices Moderate Jan 13, 2016
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116…
FDA Devices Critical Dec 30, 2015
Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 4…
FDA Devices Critical Nov 18, 2015
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (sin…
FDA Devices Critical Nov 18, 2015
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H8022333…
FDA Devices Moderate Nov 18, 2015
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
FDA Devices Moderate Sep 23, 2015
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU…
FDA Devices Moderate Sep 23, 2015
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU200…
FDA Devices Moderate Aug 19, 2015
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. …
FDA Devices Moderate Aug 19, 2015
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. …
FDA Devices Moderate Aug 19, 2015
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. F…
FDA Devices Moderate Jul 8, 2015
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX …
FDA Devices Moderate Jun 24, 2015
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as…
FDA Devices Moderate Apr 8, 2015
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
FDA Devices Moderate Apr 8, 2015
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD…
FDA Devices Critical Jan 21, 2015
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; …
FDA Devices Moderate Oct 15, 2014
StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
FDA Devices Moderate Jun 25, 2014
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conj…
FDA Devices Moderate Jun 25, 2014
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in co…
FDA Devices Moderate Jun 25, 2014
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in …
FDA Devices Moderate Jun 25, 2014
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in co…
FDA Devices Moderate Apr 30, 2014
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
FDA Devices Moderate Mar 19, 2014
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
FDA Devices Moderate Feb 19, 2014
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
FDA Devices Moderate Jan 22, 2014
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific…
FDA Devices Moderate Jan 22, 2014
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter …
FDA Devices Moderate Jan 22, 2014