FIRMap 60mm Catheter — Class III medical device recall Z-2478-2015
Terminated recall by Abbott Electrophysiology, reported 2015-09-09, distributed in AZ, CA, CO, CT, FL, GA, IL, IN…. The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to custom
| Recall number | Z-2478-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Electrophysiology, Menlo Park, CA, United States |
| Recall initiated | 2015-08-12 |
| Classified | 2015-08-28 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2015-09-23 |
| Distributed | AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NJ, NY, OH, PA, TN, TX, VA, WA |
| Quantity | 86 units |
| Reason classes | labeling |
| Lot numbers | TPR031615-01 |
| Model numbers | USAR064060 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2478-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.