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Acutus Medical Inc recalls Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, R
Recalled April 29, 2020 · FDA recall Z-1770-2020 · Acutus Medical
Hazard
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. · FDA Class II
Units
30 units
Sold at
US: CA,SC, AZ OUS: None
Description
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.
Product
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Manufacturer(s)
Acutus Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →