Recall Z-1769-2020 ยท DYB Introducer, Catheter
Acutus Medical Inc
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
| Date | Apr 23, 2020 (initiated Feb 25, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | 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 |
| Quantity | 268 units |
| Distribution | US: CA,SC, AZ OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170373 | Flextra Steerable Introducer Rhythm Xience, Inc. (Rxi), Feb 27, 2017 |