Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

FIRMap 60mm Catheter Recalled by Abbott Electrophysiology Due to The expiration date was incorrectly printed on the...

Date: August 12, 2015
Company: Abbott Electrophysiology
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Electrophysiology directly.

Affected Products

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.

Quantity: 86 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 19 states: AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NJ, NY, OH, PA, TN, TX, VA, WA

Affected (19 states)Not affected

About Abbott Electrophysiology

Abbott Electrophysiology has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report