Acutus Medical Inc: Medical Device Recall in 2020 - (Recall #: Z-1770-2020)

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 Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly

Product Classification:

Class II

Date Initiated: February 25, 2020

Date Posted: April 29, 2020

Recall Number: Z-1770-2020

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: 30 units

Code Information:

Affected Lot Numbers/Expiration Date: 19052006/ May 2020 19061318/ June 2020

Distribution Pattern:

US: CA,SC, AZ OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated