Acutus Medical Inc recalls Rhythm Xience Flextra Steerable Introducer with Lancer Integ
Recalled Product
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Hazard / Issue
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Issued by
FDA
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