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During the execution of 2 year real time aging, an issue was identified during bubble testing where there was a leak in the sealed sterile barrier of the packaging. Further investigation determined the manufacturing work instruction was not aligned to…

During investigational testing of the Habib™ Catheter with the ERBE VIO 3 generator (compatible 3rd party device), an issue with the generator setting in the Habib™ IFU (50738103) was identified. From the results of this testing, it was…

Boston Scientific (BSC) initiated a field action in October 2022, communicating that remnant orise gel post-procedure can cause a foreign body reaction, appearing as mass formations and submucosal distortions. Since this time, BSC has become aware of…

A subset of Emblem S-ICDs was manufactured in September and has an incorrect date/timestamp which may cause an inaccurate display of battery capacity. The device's manufacturing date/timestamp is used by the programmer and latitude™ patient management…

Boston Scientific recently became aware of events associated with foreign body reaction which presented as mass formations from remnant Orise gel post procedure, prompting unnecessary surgical intervention at a rate of 0.0019% of units sold (based on…

Boston Scientific Corporation is initiating an advisory to inform customers that if limited supply of model 3300 latitude programmers exists locally, Boston Scientific recommends continued use of older model 3120 zoom programmers. Consequently, users may…

In December 2020, Boston Scientific committed to developing a software enhancement that detects and alerts Healthcare Professionals (HCPs) if an Emblem S-Icd exhibits hydrogen-induced accelerated battery depletion. This enhanced software allows…

Boston Scientific is conducting a removal of specific batches of rotawire drive and wireclip torquer after determining that a small number of pouches containing these products may have a weak seal, which could open during normal shipping and handling and…

Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to…

Boston Scientific received three reports of embolism that occurred outside of the pelvis. These events occurred as a result of inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis. As a…

Boston Scientific Corporation (BSC) is initiating a removal of specific lots/batches of Hurricane RX Biliary balloon dilatation catheters in response to an increase in complaints reported for Pinholes in the balloon. The user may notice…