REPROCESSED DECANAV EP CATHETER, F CURVE
Received May 7, 2026 · Event occurred Apr 15, 2026
Report 2134070-2026-00010 · MDR key 25118340
Device
Generic name
Catheter, Recording, Electrode, Reprocessed
Manufacturer
Sterilmed, Inc.Catalog number
RR7F282CT
Lot number
2253778
Product problems
- Delivered as Unsterile Product
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A SHIPMENT OF REPROCESSED DECANAV EP CATHETER, F CURVE, WAS RECEIVED AND THE BOXES WERE DAMAGED (SMASHED). THE CATHETERS INSIDE WERE COMPROMISED, THE INSIDE PACKAGING WAS ALSO DAMAGED. THERE WAS NO PROCEDURE INVOLVED. BASED ON THE SEVERITY OF THE DAMAGE, IT IS POSSIBLE THE STERILITY WAS COMPROMISED.