Tag: boston_scientific

FDA Issues Early Alert for Boston Scientific ENROUTE System Recall

24 Jul 2026 3:44 p.m. · Source: US Food and Drug Administration

Boston Scientific is recalling specific lots of its ENROUTE Transcarotid Neuroprotection System and System Plus due to arterial sheath tip separation, which can lead to serious complications like stroke. The FDA has issued an Early Alert.

Health Business Science & Technology Medical Science Federal Government Boston Scientific ENROUTE Medical Device Product Recall Neuroprotection System Tip Separation FDA Food Recalls Drugs
Boston Scientific Issues Class I Recall and Software Correction for ACCOLADE Pacemakers

7 May 2026 3:54 p.m. · Source: US Food and Drug Administration

Boston Scientific has issued a Class I recall for ACCOLADE pacemakers and CRT-Ps, requiring a critical software update. The FDA warns that failing to correct the devices could lead to early replacement, serious injury, or death.

Health Science & Technology Business Medical Science Computers and Internet Legal Federal Government Product Recall Medical Devices Boston Scientific Pacemakers FDA Health and Wellness Software Update Food Recalls Drugs