Boston Scientific Corporation
Boston Scientific Corporation: 20 recalls listed since January 2026 across FDA; 4 rated high risk.
By year
- 202620
By agency
- FDA20
By category
- Medical Device20
All recalls (20)
Boston Scientific NaviFlex LW Pusher and Advx Panc Stent
The device was incorrectly manufactured with a guidewire exit port, which is not a design feature.
Imager II Angiographic Catheters
Imager II Angiographic Catheters may fracture or detach, leading to device fragments remaining or migrating.
Boston Scientific StoneSmart Connect Console
The StoneSmart Connect Console has power adapters with higher-than-expected resistance in the electrical grounding path.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System
The Insertable Cardiac Monitor System may delay AF Burden Alert notifications, potentially delaying clinical evaluation.
3 products
Boston Scientific ENROUTE Transcarotid Neuroprotection System
The ENROUTE Transcarotid Neuroprotection System has a potential for arterial sheath tip separation during use.
2 products
Boston Scientific OverStitch Suture Cinch and Suture Cinch Long
The OverStitch Suture Cinch may fail to deploy the cinch implant or cut the suture.
2 products
Boston Scientific Radial Jaw 4 Biopsy Forceps
Radial Jaw 4 Standard Capacity Biopsy Forceps may have a breach in the sterile barrier of their packaging.
3 products
Boston Scientific TheraSphere 360 Y-90 Management Platform
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input.
Boston Scientific FARADRIVE Steerable Sheath Clear
The FARADRIVE Steerable Sheath Clear can have valve damage that may cause air ingress and potential air embolism.
4 products
Boston Scientific FARASTAR Ablation Generator and Cardiac Ablation Catheter
The Farastar Ablation Generator has a configuration not compatible with the Farapoint catheter.
Boston Scientific FARASTAR Ablation Generators and Cardiac Ablation Catheters
Farastar ablation generators and catheters have labeling that does not include Farapoint PFA catheter information.
3 products
Boston Scientific Rapid Refill Continuous Injection System
The Rapid Refill Continuous Injection System contains a syringe that may loosen or disconnect, causing fluid leakage or separation.
Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators
Potential sterile breach of the pouches in which devices are packaged.
12 products
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump
The Intera Oncology Intera 3000 Hepatic Artery Infusion Pump has potential for leakage along the drug pathway.
Boston Scientific Orca Single Use Air/Water and Suction Valves
Orca Single Use Air/Water and Suction Valves have a suction button that can stick.
Boston Scientific LUX-Dx II Arrhythmia Detectors and Alarms
The LUX-DX II Arrythmia detector and alarm may not collect PVC Burden data or monitor for Bradyarrhythmia and Pause.
2 products
Boston Scientific Essentio, Proponent, Valitude and Visionist Pacemakers
Boston Scientific pacemakers may have a software issue that could affect therapy.
2 products
EndoVive Safety PEG Kit
The EndoVive Safety PEG Kit contains ChloraPrep Triple Swabsticks with open or compromised seals.
Boston Scientific AXIOS and HOT AXIOS Stent and Delivery Systems
AXIOS Stent and Electrocautery-Enhanced Delivery Systems may have deployment and expansion issues.
6 products
Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters
The Coyote balloon catheter may not inflate or deflate properly during use.
