FDA Device recall Z-2478-2015
FIRMap 60mm Catheter
- FDA Device
- Class III
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class III recall of FIRMap 60mm Catheter by Abbott Electrophysiology, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2478-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-08-12 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Electrophysiology |
| Distribution | AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NJ, NY, OH, PA, TN, TX, VA, WA |
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.
Reason
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.
Identifiers
| code_info | Model number : USAR064060; Lot code: TPR031615-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2478-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.