FDA-Device2020-04-29Class II
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Acutus Medical Inc
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.
Sold states
US: CA,SC, AZ OUS: None
Affected count
108 units
Manufactured in
2210 Faraday Ave Ste 100, N/A, Carlsbad, CA, United States
Products
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2020Don't want to check this manually?
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