Z-2478-2015Class III

FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number...

Name: Z-2478-2015 FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number...
Creator: Abbott Electrophysiology
Published: 2015-08-12
License: https://open.fda.gov/license/

Abbott Electrophysiology / initiated 2015-08-12 / Terminated / root cause: labeling and UDI

FDA source

Abbott Electrophysiology began a recall of 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... on 2015-08-12. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2478-2015
Classification: Class III
Status: Terminated
Initiated: 2015-08-12
Posted: 2015-08-28
Terminated: 2015-09-23
Recalling firm: Abbott Electrophysiology
Product: 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 code: MTD Catheter, Intracardiac Mapping, High-Density Array
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: The firm, Abbott Electrophysiology, sent an "URGENT PRODUCT RECALL" letter dated August 11, 2015. A customer recall notification letter was distributed to firm representatives who will visit each consignee and inspect inventory for affected product. Letters were provided to reps on August 12, 2015. The letter describes the product, problem and actions to be taken. The customers were informed that the product they have in stock will be return to the firm and will be provided a replacement product free of charge. If you have any questions, contact Quality Director at 650-681-1744.
Quantity in commerce: 86 units
Distribution: 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.
Product codes and lots: Model number : USAR064060; Lot code: TPR031615-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2478-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2478-2015	Class III	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-28

Product code MTD

K130827Class IIFirmap CatheterTopera, Inc. / cleared 2013-10-31

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)