Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Recall
- Recall Number
- Z-1771-2020
- Event Number
- 85197
- Firm
- Acutus Medical Inc
- FEI Number
- 3012120746
- Product Code
- DYB
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- February 25, 2020
- Posted
- April 23, 2020
- Terminated
- April 27, 2021
- Address
- 2210 Faraday Ave, Ste 100, Carlsbad, CA, 92008-7225
Description
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
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.
The firm mailed a "Urgent: Medical Device Recall notification" letter to affected consignees on February 25, 2020 and March 5, 2020. In addition to informing consignees about the recalled product, the recall notification asked consignees to take the following actions: 1. Please immediately identify and quarantine any unused product and return this product to your Acutus Medical Representative immediately. Replacement product will be provided in approximately one month at no additional cost. 2. Please also kindly complete the acknowledgement form found on Page 3 of this letter and return the acknowledgement to Acutus Medical using the self-addressed stamped envelope. 3. For additional information regarding the issue discussed above, please contact Steven McQullan at 442-232-6080 or contact your local Acutus Medical Representative directly.
US: CA,SC, AZ OUS: None
5 units