Device Recall
FDA•MODERATE
LUX-Dx Insertable Cardiac Monitor System Software
Boston Scientific recalls LUX-Dx ICM server software (Model 7260) over delayed AF Burden Alerts.
3 productsBoston Scientific Corporation
Boston Scientific Corporation: 15 recalls listed since March 2026 across FDA; 2 rated CRITICAL.
By year
- 202615
By agency
- FDA15
By category
- Medical Device15
All recalls (15)
FDA•CRITICALENROUTE Transcarotid Neuroprotection SystemBoston Scientific recalls ENROUTE Transcarotid Neuroprotection System over sheath tip separation risk.
2 products
FDA•MODERATEOverStitch Suture CinchBoston Scientific recalls OverStitch Suture Cinch over deployment and suture-cutting failures.
2 products
FDA•MODERATERadial Jaw 4 Biopsy ForcepsBoston Scientific recalls Radial Jaw 4 biopsy forceps due to sterile barrier breach risk.
4 products
FDA•MODERATETheraSphere 360 Y-90 Management PlatformBoston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.
4 products
FDA•MODERATEFARASTAR Ablation Generator and FARAPOINT CatheterBoston Scientific recalls FARASTAR generator and ablation catheter due to missing IFU info for FARAPOINT catheter.
3 products
FDA•MODERATEBoston Scientific FARASTAR PFA GeneratorBoston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
FDA•MODERATEBoston Scientific Rapid Refill Continuous Injection SystemBoston Scientific is recalling the Rapid Refill Continuous Injection System due to a risk of syringe disconnection during use.
FDA•MODERATECRE Pro Wireguided DilatorBoston Scientific recalls CRE Pro Wireguided dilator due to potential sterile pouch breach.
12 products
FDA•MODERATEIntera 3000 Hepatic Artery Infusion PumpIntera 3000 Hepatic Artery Infusion Pump recalled over potential drug pathway leakage.
FDA•MODERATEBoston Scientific Orca Air/Water and Suction ValvesBoston Scientific is recalling Orca single-use air/water and suction valves due to reports of the suction button sticking during use.
FDA•MODERATEBoston Scientific LUX-DX II Arrhythmia DetectorBoston Scientific recalls LUX-DX II Arrhythmia Detector (M302) with LATITUDE DRAGON US Server (6460) over missing PVC Burden and Bradyarrhythmia monitoring.
2 products
FDA•CRITICALBoston Scientific PacemakersBoston Scientific updates software for certain pacemakers and CRT-Ps due to bradycardia maintenance release.
3 products
FDA•MODERATEEndoVive Safety PEG KitBoston Scientific is recalling EndoVive Safety PEG Kits due to compromised seals on the included antiseptic swabsticks.