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Acutus Medical Inc recalls Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxO
Recalled April 29, 2020 · FDA recall Z-1768-2020 · 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
108 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 Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Manufacturer(s)
Acutus Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →