Boston Scientific Corporation Recalls — US Product Safety History

Boston Scientific Corporation recalls EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M

Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.

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Boston Scientific Corporation recalls Boston Scientific Cardiac Resynchronization Therapy (CRT)lab

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

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Boston Scientific Corporation recalls Boston Scientific Pacemaker, Implantable Pulse Generator, Pa

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

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Boston Scientific Corporation recalls LUX-DX II, Arrythmia detector and alarm, Model M302, with SE

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

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Boston Scientific Corporation recalls LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, wi

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

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Boston Scientific Corporation recalls Orca Single Use Air/Water and Suction Valves, Material Numbe

Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

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Boston Scientific Corporation recalls Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

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Boston Scientific Corporation recalls CRE Pro Wireguided 12-15mm 240cm