Abbott Electrophysiology: Medical Device Recall in 2015 - (Recall #: Z-2478-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

Product Classification:

Class III

Date Initiated: August 12, 2015

Date Posted: September 9, 2015

Recall Number: Z-2478-2015

Event ID: 71970

Reason for Recall:

The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.

Status: Terminated

Product Quantity: 86 units

Code Information:

Model number : USAR064060; Lot code: TPR031615-01

Distribution Pattern:

US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated