The company said the consoles meet design specifications and are expected to perform as intended, as Boston Scientific determined that the correct use of the device should not be impacted by the missing manual.
However, due to the console’s interactive features, the procedure could be delayed without the manual. The company did not observe any adverse health consequences and expect none to occur as a result of the issue and said no product is being recalled, despite the safety notice.
Boston Scientific instructed users to ensure that they have read the field safety notice and present the information in a visible place near the product so all users are aware. The company included the missing manual with the field safety notice.
The AngioJet is a pharmacomechanical peripheral thrombectomy device that includes active aspiration and Power Pulse lytic delivery. It is designed to treat the widest range of thrombosed vessels by rapidly restoring blood flow, according to Boston Scientific’s website.