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CORE DYNAMICS CD8190Recalls & reported problems

Conmed Corporation · CORE Trumpet For Single or Dual Solution Bag · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405046219), received between Mar 27, 2020 and Mar 27, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Activation, Positioning or Separation Problem1
  • Patient Device Interaction Problem1
  • Physical Resistance/Sticking1

Patient problems

  • Blood Loss1
  • Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 27, 2020Activation, Positioning or Separation Problem; Patient Device Interaction Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Patient Device Interaction Problem; Physical Resistance/Sticking

    ON BEHALF OF THE CUSTOMER, THE DISTRIBUTOR REPORTED AN ISSUE WITH THE CORE TRUMPET 5X32CM, ITEM # CD8190, LOT 201905244 THAT OCCURRED (B)(6) 2020 DURING AN UNKNOWN GYNECOLOGICAL PROCEDURE. IT WAS REPORTED THAT THE "SUCTION/IRRIGATION PRODUCT'S SUCTION BUTTON GOT STUCK SO THAT SUCTION CONTINUES EVEN THOUGH THE BUTTON ITSELF IS RELEASED. FIRST INSTRUMENT STAYED IN CONTINUOUS SUCTION, SO A NEW CORE INSTRUMENT WAS NEEDED. THE SECOND ONE ALSO GOT STUCK TO CONTINUOUS SUCTION. THE BOWEL SUCKED INSIDE TO THE INSTRUMENTS INNER LUMEN SIMULTANEOUSLY WITH THE FATTY TISSUE CLOSED THE DISTAL TUBING HOLES OUTSIDE FROM THE INSTRUMENT. THE SUCTION DEVICE WAS SHUT DOWN AND THE INSTRUMENT RELEASED. THE BOWEL WAS HEAVILY STUCK INSIDE THE CORE INSTRUMENT. BLEEDING FROM THE BOWEL OUTER LAYER WAS CONTROLLED SOME MINUTES AFTER THE INCIDENT." IT IS INDICATED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY BUT LENGTH OF TIME NOT MADE AVAILABLE. ADDITIONAL INFORMATION OBTAINED CLARIFIED THAT THE LOT NUMBERS OF BOTH DEVICES MENTIONED AND USED WERE THE SAME, LOT 201905244. DURING THE FIRST QUARTER OF THE PROCEDURE, WHILE THE DEVICE SETTING WAS 12MMHG, IT WAS REPORTED THAT AS THE SUCTION CONTINUED, PART O

    Patient problems: Blood Loss; Injury

    MAUDE report 9890877 ↗

Other CATHETER, PERITONEAL devices

All CATHETER, PERITONEAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.