- Boston Scientific NaviFlex LW Pusher and Advx Panc Stent (opens in a new tab)
Moderate risk, FDA, , Device defect
- Imager II Angiographic Catheters (opens in a new tab)
High risk, FDA, , Device defect
- Boston Scientific StoneSmart Connect Console (opens in a new tab)
Moderate risk, FDA, , Device defect
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System (opens in a new tab)
Moderate risk, FDA, , Software defect
- Boston Scientific ENROUTE Transcarotid Neuroprotection System (opens in a new tab)
High risk, FDA, , Device defect