Boston Scientific recalls
Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- PROPONENT MRI Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - PROPONENT SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ACCOLADE MRI EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - VISIONIST X4 CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ACCOLADE SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - PROPONENT VDD SL Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - PROPONENT EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - PROPONENT DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO MRI SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ALTRUA 2 EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO MRI DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - VISIONIST CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ACCOLADE DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - VALITUDE CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - VALITUDE X4 CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - MOMENTUM X4 CRT-D, Model G138, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - RESONATE X4 CRT-D, Model G447, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - RESONATE EL ICD VR, Model D432, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - RESONATE EL ICD DR, Model D433, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - VIGILANT X4 CRT-D, Model G247, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices…
FDA Device · Class II · 2017-09-20 · Boston Scientific - Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
FDA Device · Class II · 2017-08-23 · Boston Scientific - SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-thr…
FDA Device · Class II · 2017-08-23 · Boston Scientific - EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide d…
FDA Device · Class II · 2017-08-23 · Boston Scientific - EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide…
FDA Device · Class II · 2017-08-23 · Boston Scientific - Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system
FDA Device · Class II · 2017-07-12 · Boston Scientific - Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
FDA Device · Class II · 2017-07-12 · Boston Scientific - Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
FDA Device · Class II · 2017-07-12 · Boston Scientific - The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vas…
FDA Device · Class II · 2017-05-10 · Boston Scientific - Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
FDA Device · Class II · 2017-04-19 · Boston Scientific - AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls…
FDA Device · Class II · 2017-03-15 · Boston Scientific - Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer
FDA Device · Class II · 2017-02-15 · Boston Scientific - Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly
FDA Device · Class II · 2017-01-11 · Boston Scientific - Pacemakers: Accolade MRI DR Model L311
FDA Device · Class II · 2016-09-14 · Boston Scientific - Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a perma…
FDA Device · Class II · 2016-05-04 · Boston Scientific - Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001
FDA Device · Class I · 2016-04-27 · Boston Scientific - Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H74914902…
FDA Device · Class II · 2016-04-20 · Boston Scientific - Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211
FDA Device · Class II · 2016-01-20 · Boston Scientific - Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker
FDA Device · Class II · 2016-01-20 · Boston Scientific - Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8…
FDA Device · Class II · 2016-01-13 · Boston Scientific - Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath…
FDA Device · Class I · 2015-12-30 · Boston Scientific - IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS
FDA Device · Class II · 2015-12-30 · Boston Scientific - IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10
FDA Device · Class II · 2015-12-30 · Boston Scientific - IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40
FDA Device · Class II · 2015-12-30 · Boston Scientific - IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS
FDA Device · Class II · 2015-12-30 · Boston Scientific - One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube
FDA Device · Class II · 2015-12-16 · Boston Scientific - RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support
FDA Device · Class I · 2015-11-18 · Boston Scientific