Z-1769-2020Class II

Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle...

Name: Z-1769-2020 Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle...
Creator: Acutus Medical Inc
Published: 2020-02-25
License: https://open.fda.gov/license/

Acutus Medical, Inc. / initiated 2020-02-25 / Terminated / root cause: manufacturing process

FDA source

Acutus Medical Inc began a recall of Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly on 2020-02-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1769-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-25
Posted: 2020-04-23
Terminated: 2021-04-27
Recalling firm: Acutus Medical, Inc.
Product: Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 268 units
Distribution: US: CA,SC, AZ OUS: None
Product codes and lots: Affected Lot Numbers/Expiration Date: 19101021 /October 2020 19103124 /October 2020 19121604 /December 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1769-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1768-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1769-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1770-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1771-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23

Product code DYB

K170373Class IIFlextra Steerable IntroducerRhythm Xience, Inc. (Rxi) / cleared 2017-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)