Tag: boston_scientific

FDA Issues Class I Recall for Boston Scientific Spinal Cord Stimulator Leads

3 Sep 2026 4:18 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's unused Infinion CX Leads, part of Spinal Cord Stimulator Systems. Mechanical stress can cause lead fractures, leading to inadequate stimulation and 1,081 reported serious injuries. This recall affects only…

Health Business Politics and Government Medical Science Federal Government Legal Boston Scientific Infinion CX Leads Spinal Cord Stimulator FDA Product Recall Medical Devices Class I Recall Food Recalls Drugs
Boston Scientific Recalls Angiographic Catheters Over Tip Detachment Risk

28 Aug 2026 1:58 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Boston Scientific's Imager II Angiographic Catheters, which are being recalled due to a manufacturing defect risking tip detachment. Two serious injuries have been reported, prompting the company to discontinue the product.

Health Business Politics and Government Medical Science Federal Government Legal Boston Scientific Imager II Angiographic Catheters FDA Medical Device Recall Tip Detachment Embolism Early Alert Food Recalls Drugs
FDA Issues Class I Recall for Boston Scientific ENROUTE Catheters

26 Aug 2026 11:16 a.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's ENROUTE Transcarotid Neuroprotection System and Plus, citing potential for serious injury or death. This urgent action requires removal of affected percutaneous catheters from use.

Health Business Politics and Government Medical Science Federal Government Legal Product Recall Medical Device Boston Scientific FDA ENROUTE Transcarotid Neuroprotection System Class I Recall Percutaneous Catheter Food Recalls Drugs
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

Tag: boston_scientific

FDA Issues Class I Recall for Boston Scientific Spinal Cord Stimulator Leads

Boston Scientific Recalls Angiographic Catheters Over Tip Detachment Risk

FDA Issues Class I Recall for Boston Scientific ENROUTE Catheters

FDA Issues Early Alert for Boston Scientific ENROUTE System Recall

Boston Scientific Issues Class I Recall and Software Correction for ACCOLADE Pacemakers