Home / Recalls / Acutus Medical Inc / Z-1769-2020

Z-1769-2020 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
268 units

Product Description

Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated 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: 19101021 /October 2020 19103124 /October 2020 19121604 /December 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-1768-2020 Class II — Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transse (February 25, 2020)
  • Z-1771-2020 Class II — Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Di (February 25, 2020)