Home / Recalls / Acutus Medical Inc / Z-1768-2020

Z-1768-2020 Class II Terminated

Recalled by Acutus Medical Inc — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
April 29, 2020
Initiation Date
February 25, 2020
Termination Date
April 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
108 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

US: CA,SC, AZ OUS: None

Code Information

Affected Lot Numbers/Expiration Date: 19040503 /April 2020 19052007 /May 2020 19061317 /June 2020

Other recalls by Acutus Medical Inc

  • Z-1770-2020 Class II — Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transs (February 25, 2020)
  • Z-1771-2020 Class II — Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Di (February 25, 2020)
  • Z-1769-2020 Class II — Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated D (February 25, 2020)