Boston Scientific Corp.

Reports per year

Source: FDA adverse event reports by year received, 2010–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Coronary Drug-Eluting StentNIQ2,688
• Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX547
• Stent, CoronaryMAF365
• Catheter, Intravascular, DiagnosticDQO233
• Catheter, Angioplasty, Peripheral, TransluminalLIT226
• Stents, Drains And Dilators For The Biliary DuctsFGE207
• Wire, Guide, CatheterDQX188
• Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS118
• Tubes, Gastrointestinal (And Accessories)KNT110
• Instrument, BiopsyKNW79

Recent recalls

• 2015-12-10TerminatedUnder Investigation by firm

  One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

  Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.

• 2015-03-02TerminatedDevice Design

  IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.

  Reports of formation of char adherent to the proximal part of the distal tip electrodes

• 2014-12-10TerminatedDevice Design

  IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

  Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.

• 2011-01-27TerminatedNonconforming Material/Component

  RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000xp Cardiac Ablation Controllers and Foot Switch are indicated for use in cardiac ablation procedures with standard and high power BSC cardiac ablation Catheters.

  Product malfunction causes inadvertent delivery of energy.

• 2010-03-17TerminatedNonconforming Material/Component

  CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific Corporation, San Jose, CA. The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.

  Product failure-- Product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. A component on the circuit board fails unexpectedly because of a power surge, causing a diode to burn out.

• 2009-11-11TerminatedOther

  Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.

  The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."

• 2009-09-09TerminatedProcess control

  Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.

  The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.

• 2009-09-09TerminatedProcess control

  Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation.

  The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.

• 2009-04-09TerminatedProcess design

  Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Manufactured by Thomas Medical Products, Malvern, PA. Product is intended for use to facilitate the intracardiac placement of interventional devices.

  The marker band may detach from the sheath and a clinical failure could result in an embolism.

• 2009-04-09TerminatedProcess design

  Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Manufactured by Thomas Medical Products, Inc. Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath.

  The marker band may detach from the sheath and a clinical failure could result in an embolism.