Z-1769-2020 Class II Terminated
FDA device recall Z-1769-2020 was initiated by Acutus Medical Inc on February 25, 2020 and is designated Class II. 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 emboli… The recall status is terminated (terminated April 27, 2021). Affected quantity: 268 units.
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