Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
FDA Recall Z-1768-2020 · Posted 2020-04-23
Advertisement
Recalling FirmAcutus Medical Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2020-02-25
Date Terminated2021-04-27
Product Quantity108 units
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.
Firm 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 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.
Root Cause
Process design
Distribution Pattern
US: CA,SC, AZ OUS: None
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement