Acutus Medical Inc: Medical Device Recall in 2020 - (Recall #: Z-1768-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly

Product Classification:

Class II

Date Initiated: February 25, 2020

Date Posted: April 29, 2020

Recall Number: Z-1768-2020

Event ID: 85197

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.

Status: Terminated

Product Quantity: 108 units

Code Information:

Affected Lot Numbers/Expiration Date: 19040503 /April 2020 19052007 /May 2020 19061317 /June 2020

Distribution Pattern:

US: CA,SC, AZ OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated