NA 5846V (UDI 00643169307384)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169307384), received between Mar 28, 2022 and Mar 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2022Connection Problem

  THERE WAS A SECOND EVENT WITH THE EDWARDS SWAN GANZ PACER CATHETER AND THE MEDTRONIC 5846V PACER CABLE WHEREBY THEY DO NOT STAY CONNECTED. THE BEDSIDE RN WAS AWARE OF THE FIRST EVENT AND SO THE NURSE TAPED THE WIRES INTO THE ADAPTER PORT WHEN THEY NOTICED THE WIRES/PRONGS WERE NOT STAYING IN PLACE. FORTUNATELY THE PATIENT DID NOT NEED PACING AND MAINTAINED A NATIVE RHYTHM. IN FOLLOW UP, CONTACT WAS MADE WITH THE MEDTRONIC REPRESENTATIVE. REPRESENTATIVE SENT A FEW INSTRUCTIONS FOR USE AND OUR NURSE SPECIALIST AND REPRESENTATIVE MET VIA TEAMS VIDEO AND NURSE DEMONSTRATED THE PACER CABLE, EDWARDS CABLE AND THE ISSUE OF POOR CONNECTION. DISCUSSION IS UNDERWAY WITH MEDTRONIC AND EDWARDS REGARDING THE USE OF ADAPTER PINS. THESE ADAPTER PINS ARE CALLED DINAPT AND CAN BE ORDERED AND USED ON THE CATHETERS TO IT INTO THE REUSABLE CABLES (5492VL AND 5492AL). MORE FOLLOW UP ON THE ADAPTOR WILL BE DONE. (WHEN WE CALLED IN AN ORDER FOR THE CURRENT DISPOSABLE CABLE, 5846V, WE LEARNED THAT THIS HAS BEEN DISCONTINUED AND THAT ALL EPG PRODUCTS HAVE GONE AWAY FROM THE 6 FT LENGTH TO THE 12 FT LENGTH.)

  Patient problems: Insufficient Information

  MAUDE report 13927981 ↗
• MalfunctionMar 28, 2022Connection Problem

  PATIENT CAME IN WITH 3RD DEGREE BLOCK AND NEEDED A TRANSVENOUS CATHETER. EDWARDS SWAN GANZ PACER CATHETER REF D9120FS DOES NOT STAY CONNECTED TO OUR NEW PACER CABLES FROM MEDTRONIC 5846V. THE CONNECTION IS NOT SECURE AND LIKELY MORE OF THE PACER CABLE ISSUE SINCE THIS IS NEW. THE BEDSIDE RN NEEDED TO MANUALLY HOLD THE TWO CONNECTIONS TOGETHER IN ORDER TO KEEP ELECTRICITY FOR THE PATIENT SO THEY WOULD CONTINUE TO PACE ALL THE WAY TO THE CATH LAB UNTIL THEY RECEIVED A NEW PACER. IN FOLLOW UP, CONTACT WAS MADE WITH THE MEDTRONIC REPRESENTATIVE. REPRESENTATIVE SENT A FEW INSTRUCTIONS FOR USE AND OUR NURSE SPECIALIST AND REPRESENTATIVE MET VIA TEAMS VIDEO AND NURSE DEMONSTRATED THE PACER CABLE, EDWARDS CABLE AND THE ISSUE OF POOR CONNECTION. DISCUSSION IS UNDERWAY WITH MEDTRONIC AND EDWARDS REGARDING THE USE OF ADAPTER PINS. THESE ADAPTER PINS ARE CALLED DINAPT AND CAN BE ORDERED AND USED ON THE CATHETERS TO IT INTO THE REUSABLE CABLES (5492VL AND 5492AL). MORE FOLLOW UP ON THE ADAPTOR WILL BE DONE. (WHEN WE CALLED IN AN ORDER FOR THE CURRENT DISPOSABLE CABLE, 5846V, WE LEARNED THAT THIS HAS BEEN DISCONTINUED AND THAT ALL EPG PRODUCTS HAVE GONE AWAY FROM THE 6 FT LENGTH TO THE 12 FT LEN

  Patient problems: Insufficient Information

  MAUDE report 13927953 ↗