CODMAN® 9190002RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780521778), received between Feb 21, 2025 and Apr 23, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDWATCH#: (B)(4). A FACILITY REPORTED: "DURING PROCEDURE, THE MALLIS IRRIGATING TUBING FOR THE BIPOLAR WAS MALFUNCTIONING. MULTIPLE TUBING PULLED FROM STOCK WITH SAME LOT NUMBER WERE OPENED AND NON-FUNCTIONING. ALL THIS TUBING WAS DISCARDED. ONCE A NEW LOT NUMBER WAS OPENED, THERE WERE NO FURTHER ISSUES IDENTIFIED. THE TEAM PULLED ALL STOCK WITH AFFECTED LOT NUMBER AND WORKED WITH FIELD REPRESENTATIVE ON REPLACING USED STOCK ITEM. NO FURTHER EVENTS HAVE BEEN REPORTED TO DATE." NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895206 ↗
• MalfunctionApr 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDWATCH # (B)(4). A FACILITY REPORTED: "CODMAN IRRIGATING BIPOLAR WAS IRRIGATING BUT NOT CAUTERIZING. WHEN THE CORD WAS SWITCHED OUT, THE DEVICE (HANDPIECE AND CONSOLE) WORKED APPROPRIATELY." THE PRODUCT PROBLEM WAS DISCOVERED DURING THE PROCEDURE WHEN TRYING TO STOP A BLEED.

  Patient problems: Insufficient Information

  MAUDE report 21773368 ↗
• MalfunctionFeb 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDWATCH: "CODMAN IRRIGATING BIPOLAR SYSTEM WAS IRRIGATING BUT NOT CAUTERIZING. RESOLVED WHEN CORD AND TUBING SET WAS CHANGED. SURGEON SAYS THIS IS AN ONGOING ISSUE, STATING, "IT'S BEEN 50/50 WITH THESE LATELY".

  Patient problems: Insufficient Information

  MAUDE report 21483105 ↗
• MalfunctionFeb 21, 2025Activation Problem; Activation Problem

  A FACILITY REPORTED: "ATTEMPTED TO USE A CODMAN IRRIGATING BIPOLAR, BUT THE DEVICE ONLY IRRIGATED AND DID NOT CAUTERIZE. WHEN THE TUBING/LEAD SET WAS REPLACED, IT WORKED APPROPRIATELY."

  Patient problems: Insufficient Information

  MAUDE report 21432805 ↗