CODMAN® 261222Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780513605), received between May 17, 2022 and Jun 18, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 26, 2025Open, Classified

   Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

   Z-0374-2026 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A PHYSICIAN REPORTED A DISPOSABLE PERFORATOR (ID 261222) FAILED TO DISENGAGE CAUSING DURAL DAMAGE, REQUIRING DURAL RECONSTRUCTION TO TREAT THE DAMAGE. A SURGICAL DELAY OF LESS THAN 30 MINUTES WAS REPORTED. THE PERFORATOR WAS USED DURING A BRAIN TUMOR REMOVAL SURGERY. THE DRILL USED WITH THE PERFORATOR WAS AN ANSPACH. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE DRILL WAS ELECTRIC OR PNEUMATIC, OR IF THE PERFORATOR CLICKED IN PLACE ON THE DRILL. IT IS ALSO UNKNOWN IF THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE. ADDITIONALLY, IT IS UNKNOWN IF A PERPENDICULAR APPROACH WAS MAINTAINED THROUGHOUT THE DRILLING PROCESS, WHETHER ANY ROCKING MOTION OCCURRED, OR IF CONSTANT DOWNWARD PRESSURE WAS APPLIED.

  Patient problems: Brain Injury

  MAUDE report 22283716 ↗
• MalfunctionSep 14, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED: "DURING THE SURGICAL PROCEDURE, WHEN PERFORATOR (ID 261222) IS ASSEMBLED IN THE COUPLING, IT IS EVIDENT THAT IT IS UNADJUSTED (LOOSE). THE SURGEON PERFORMS THE ADJUSTMENT MANUALLY. WHEN PERFORMING THE BURR PERFORATION, THE DRILL DOES NOT PERFORM THE BLOCKING WHEN PASSING THE BONE TABLE AND CONTINUES UNTIL THE DURA OF THE PATIENT." NO PATIENT INJURY REPORTED AND THE EVENT LED TO LESS THAN 30 MINUTES SURGICAL DELAY. THE DRILL WAS AN ELECTRIC PIDRIVE ENGINE (STRYKER). THE DRILL CLICKED INTO PLACE ON THE DRILL AND IT WAS HEARD WHEN ASSEMBLING IT WITH THE COUPLING AND THE BIT. RECOMMENDED RESOURCE TESTS BEING PERFORMED BETWEEN EACH HOLE AND SEVERAL TESTS WERE CARRIED OUT AT THE TIME OF FINISHING ASSEMBLING THE COUPLER WITH THE MOTOR AND CONFIGURING THE CONSOLE. THE SURGEON PERFORMED THE CRANIOTOMY AT A 90 DEGREE ANGLE. AT ALL TIMES, THEY TRIED TO MAINTAIN THE ANGLE, HOWEVER THE DRILL BECAME DISLODGED FROM THE COUPLING AT THE BEGINNING OF THE CRANIOTOMY PROCESS AND HAD TO BE REARRANGED. THEY CONFIRMED THAT CONSTANT PRESSURE WAS MAINTAINED AT ALL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745379 ↗
• InjuryAug 15, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  N/A.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17549887 ↗
• MalfunctionMar 29, 2023Peeled/Delaminated; Peeled/Delaminated

  A FACILITY REPORTED THE LABEL OF A PERFORATOR (ID 261222) CAME OFF DURING USE AND THUS FALL IN THE WOUND. NO PATIENT INJURY. THE PROCEDURE WAS DELAYED CAUSE THEY HAD TO SEARCH FOR THE PIECES OF PAPER IN THE BODY OF PATIENT BUT THERE IS NO INFORMATION ABOUT EXACT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635722 ↗
• MalfunctionNov 10, 2022Dull, Blunt; Dull, Blunt

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3014334038-2022-00254. A PHYSICIAN REPORTED A PERFORATOR (ID (B)(4)) COULDN'T DRILL THE BONE. THE PHYSICIAN FELT THE PERFORATOR WAS TOO DULL AND HAD DIFFICULTY IN PERFORATING DURING A PROCEDURE. ACCORDING TO INFORMATION RECEIVED, IT IS UNKNOWN IF WHAT DRILL WAS USED AND IF THE PERFORATOR CLICKED IN PLACE ON THE DRILL. IT IS ALSO UNKNOWN IF THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15772752 ↗
• MalfunctionNov 9, 2022Dull, Blunt; Dull, Blunt

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765206 ↗
• MalfunctionMay 17, 2022Melted; Melted

  A FACILITY REPORTED THE TOP OF THE GREEN PLASTIC OF A PERFORATOR MELTED AND WAS PRODUCING SMOKE WHILE IN USE. THE PERFORATOR WAS INSPECTED PRIOR TO USE AS INSTRUCTED; THE SPRING TESTS WERE PERFORMED; THE PLASTIC SLEEVE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414923 ↗