FDA Medical Device Recalls (openFDA)
Acutus Medical Inc: Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
- Recall number
- Z-1768-2020
- Recalling firm
- Acutus Medical Inc
- Product
- Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
- Status
- Terminated
- Initiated
- 2020-02-25
- Posted
- 2020-04-23
- Terminated
- 2021-04-27
- 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 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.
- Quantity
- 108 units
- Distribution
- US: CA,SC, AZ OUS: None
- Lot, serial or model codes
- Affected Lot Numbers/Expiration Date: 19040503 /April 2020 19052007 /May 2020 19061317 /June 2020
- 510(k) numbers
- ["K170373"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3012120746
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28