Z-1768-2020 Class II Terminated
FDA device recall Z-1768-2020 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: 108 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
- 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