Acutus Medical product recalled over foreign material

Recall date

February 25, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Acutus Medical Inc recalls Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, Rx…

Recall number

Z-1768-2020

FDA classification

Class II

Brand / firm

Acutus Medical Inc

Sold / distributed

US: CA,SC, AZ OUS: None

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly