CODMAN 26-1221Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886704005100), received between Jul 25, 2018 and Dec 17, 2024 — classified as 12 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A PERFORATOR FAILED TO DISENGAGE WHEN REACHED THE DURA MATER CAUSING DAMAGE ON THE SURFACE OF DURA MATER, TREATED WITH PATCH AND SUTURES. THE EVENT DID NOT LED TO SURGICAL DELAY. THE PERFORATOR WAS USED WITH AN ELECTRIC J&J ANSPACH DRILL. THE PERFORATOR CLICKED IN PLACE WITH THE DRILL. THE ANGLE OF APPROACH WAS PERPENDICULAR AND IT WAS MAINTAINED THROUGH THE DRILLING PROCESS WITH A CONSTANT DOWNWARD PRESSURE.

  Patient problems: Brain Injury

  MAUDE report 20953054 ↗
• InjuryOct 19, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A PHYSICIAN REPORTED DISENGAGEMENT FAILURE OF A CODMAN PERFORATOR WHILE MAKING THE SECOND BURR HOLE AT THE TENT (ID (B)(6)). DURAL DAMAGE AND BRAIN CONTUSION WERE OBSERVED AND HEMOSTASIS WAS PERFORMED. THE EVENT LED TO MORE THAN 30 MINUTES SURGICAL DELAY. THE PATIENT¿S CONDITION IS STABLE. THE MANUFACTURER OF THE DRILL USED WITH THE PERFORATOR WAS ANSPACH E-MAX. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE DRILL WAS ELECTRIC OR PNEUMATIC. IT IS ALSO UNKNOWN IF THE PERFORATOR CLICKED IN PLACE IN THE DRILL AND IF THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE. CUSTOMER ALSO INFORMED THAT IS UNKNOWN IF THE ANGLE OF APPROACH WAS PERPENDICULAR AS THE IFU STATES. IT IS UNKNOWN IF THE PERPENDICULAR APPROACH MAINTAINED THROUGH THE DRILLING PROCESS OR IF THERE WAS ANY ROCKING MOTION INCLUDED, AND UNKNOWN IF THERE WAS CONSTANT DOWNWARD PRESSURE.

  Patient problems: Brain Injury

  MAUDE report 17967955 ↗
• InjuryFeb 28, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A PHYSICIAN REPORTED DISENGAGEMENT FAILURE OF A DISPOSABLE PERFORATOR (ID 261221) DURING SURGERY AND DURAL DAMAGE WAS OBSERVED. IT OCCURRED AT MAKING THE FIRST BURR HOLE AT THE TENT. HEMOSTASIS AND DURAL SUTURING WERE PERFORMED. THE DRILL USED WAS ANSPACH. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE DRILL WAS ELECTRIC OR PNEUMATIC, OR IF THE ANGLE OF APPROACH PERPENDICULAR AS THE IFU (INSTRUCTIONS FOR USE). IT IS ALSO UNKNOWN IF THE PERPENDICULAR APPROACH MAINTAINED THROUGH THE DRILLING PROCESS OR WAS THERE ANY ROCKING MOTION INCLUDED OR IF THERE WAS A CONSTANT DOWNWARD PRESSURE.

  Patient problems: Brain Injury

  MAUDE report 16455684 ↗
• InjuryOct 11, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A PERFORATOR PLUNGED DAMAGING DURA AND BLOOD VESSELS. THE EVENT LED TO SURGICAL DELAY, UNKNOWN FOR HOW LONG. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Brain Injury

  MAUDE report 15583085 ↗
• InjuryOct 3, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A CODMAN PERFORATOR (ID 261221) DID NOT STOPPED DURING A PROCEDURE FOR REMOVAL OF BRAIN TUMOR. IT WENT THROUGH THE SKULL ONTO THE DURA AND CAUSED A DURAL TEAR REQUIRING A DURAL REPAIR. IT IS UNKNOWN IF THE EVENT LED TO SURGICAL DELAY.

  Patient problems: Brain Injury

  MAUDE report 15528127 ↗
• InjurySep 23, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A DISPOSABLE PERFORATOR (ID 261221) DID NOT STOPPED AND WENT THROUGH THE SKULL ONTO THE DURA, CAUSING A DURAL TEAR. A DURAL REPAIR WAS DONE. IT IS UNKNOWN IF THE ISSUE LED TO ANY SURGICAL DELAY.

  Patient problems: Brain Injury

  MAUDE report 15472784 ↗
• MalfunctionMar 29, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED A PERFORATOR CLUTCH DID NOT ENGAGE. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938126 ↗
• MalfunctionMar 24, 2022Mechanical Problem; Mechanical Problem

  A FACILITY REPORTED THE DRILL (ELECTRIC MEDTRONIC LEGEND DRILL ) STOPPED AND THE PERFORATOR GOT STOCK IN PATIENT'S SKULL. NO SURGICAL DELAY. THE PERFORATOR CLICKED IN PLACE IN THE DRILL.

  Patient problems: Insufficient Information

  MAUDE report 13871681 ↗
• MalfunctionMar 1, 2022Mechanical Problem; Mechanical Problem

  A FACILITY REPORTED A PERFORATOR REACHED THE PATIENT'S DURA TRIGGERING THE SAFETY MECHANISM. AFTER THAT, THE PERFORATOR COULD NOT BE REMOVED FROM THE PATIENT'S SKULL. THEREFORE, THE PERFORATOR HAD TO BE REMOVED WITH DRILL AND THE EVENT LED TO 20 MINUTES SURGICAL DELAY. "THE DURA HAS BEEN OPENED WITH THE PERFORATOR. THIS DID NOT INJURE THE PATIENT, SINCE THE DURA HAD TO BE OPENED DURING THE OPERATION ANYWAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636470 ↗
• InjuryFeb 16, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A PHYSICIAN REPORTED DISENGAGEMENT FAILURE OF A PERFORATOR CAUSING DURAL DAMAGE: A RIGHT FRONTOTEMPORAL CRANIOTOMY WAS PERFORMED. THE DURA WAS PENETRATED IN ONE PLACE AND THE REMAINING THREE PERFORATIONS WERE STOPPED SHORTLY BEFORE, AND CAREFULLY SCRAPED WITH A CUTTER BAR. THERE WAS NO EFFECT ON THE BRAIN PARENCHYMA AND THE PATIENT'S CONDITION IS STABLE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE AND LESS THAN 30 MINUTES SURGICAL DELAY WAS REPORTED. THE DRILL USED WITH THE PERFORATOR WAS A MIDAS (MEDTRONIC). IT IS UNKNOWN IF THE DRILL WAS ELECTRONIC OR PNEUMATIC, IF THE PERFORATOR CLICKED IN PLACE IN THE DRILL. IT IS ALSO UNKNOWN IF THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE.

  Patient problems: Brain Injury

  MAUDE report 13543069 ↗
• MalfunctionNov 23, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  2 OF 2 REPORTS (SAME FAILURE; DIFFERENT PATIENTS). OTHER MFG REPORT NUMBER: 3014334038-2021-00237. A FACILITY REPORTED A PERFORATOR FAILED TO DISENGAGE AFTER SKULL PENETRATION. THERE WAS NO PATIENT INJURY; THE SURGEON STOPPED THE DRILL MANUALLY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865498 ↗
• MalfunctionNov 23, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  1 OF 2 REPORTS (SAME FAILURE; DIFFERENT PATIENTS). OTHER MFG REPORT NUMBER: 3014334038-2021-00240. A FACILITY REPORTED A PERFORATOR FAILED TO DISENGAGE AFTER SKULL PENETRATION. THERE WAS NO PATIENT INJURY; THE SURGEON STOPPED THE DRILL MANUALLY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865495 ↗
• InjuryJul 17, 2020Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT THE CODMAN DISPOS PERFORATOR CAME OFF FROM THE DRILL DRIVE UPON STARTING IT PRIOR TO USE ON PATIENT. THE DRILL WAS REATTACHED AND STARTED IT AGAIN BUT IT STILL CAME OFF FROM THE DRILL. THEREFORE, IT WAS REPLACED TO A NEW ONE AND THE PROCEDURE WAS COMPLETED. THE EVENT LEAD TO 30 MINUTES SURGICAL DELAY.

  Patient problems: Injury

  MAUDE report 10292995 ↗
• MalfunctionJun 19, 2020Device Remains Activated

  PATIENT WAS UNDERGOING A LEFT FRONTAL CRANIOTOMY WHEN THE BLADE OF THE CODMAN PERFORATOR BURR DID NOT STOP SPINNING WHEN THE INNER TABLE OF THE SKULL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10173427 ↗
• MalfunctionJul 25, 2019Defective Device; Defective Device

  N/A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829504 ↗
• MalfunctionJul 15, 2019Defective Device

  WHILE IN USE FOR RIGHT DEEP BRAIN STIMULATOR GENERATOR INSERTION, THE PERFORATOR DID NOT STOP AS IT SHOULD AND PENETRATED THROUGH THE BONE OF PATIENT'S SKULL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8788948 ↗
• InjuryAug 2, 2018Failure to Auto Stop; Failure to Auto Stop

  AS REPORTED BY THE SALES REP, A PERFORATOR FAILED TO DISENGAGE. THE SUPERIOR SAGITTAL SINUS WAS BREACHED AND THE PATIENT HAD A 700-800 CC BLOOD LOSS OVER 3-5 MINUTES. AS A RESULT, THE PATIENT SUFFERED 2 SMALL STROKES.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 7743687 ↗
• MalfunctionAug 2, 2018Material Fragmentation; Material Fragmentation

  AS REPORTED BY THE SALES REP, A PERFORATOR FELL APART AFTER USE. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7743055 ↗
• InjuryAug 1, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE THE PERFORATOR BROKE APART. WHEN THE SURGEON TRIED TO MAKE THE HOLE, THE SEALED PART GOT CAUGHT, AND IT PEELED APART. THOSE PIECES SCATTERED INTO THE SKIN WERE REMOVED. THERE WAS NO REPORTED ADVERSE EVENTS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL. THE PRODUCT WILL BE RETURNED TO YOUR SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739942 ↗
• InjuryJul 30, 2018Failure to Auto Stop; Failure to Auto Stop

  AS REPORTED BY THE AFFILIATE, A PERFORATOR FAILED TO DISENGAGE, PERFORATING THE DURA.

  Patient problems: Tissue Damage

  MAUDE report 7731306 ↗
• InjuryJul 25, 2018Failure to Auto Stop; Failure to Auto Stop

  AS REPORTED BY THE AFFILIATE, A PERFORATOR FAILED TO DISENGAGE AT THE DURA MATER, CAUSING A CEREBRAL CONTUSION. THE SECURE SYSTEM LEADING TO DISENGAGE OF PERFORATOR HAS NOT BEEN ACTIVATE THAT LEADING TO A CEREBRAL CONTUSION (WITHOUT INJURY, HEMORRHAGE OR CEREBRAL DISINTEGRATION), NO FURTHER INTERVENTION WAS NEEDED. THE DRILL BIT HAS BEEN REMOVED AND THERE WAS NO VITAL RISK FOR THE PATIENT. MICROSCOPICALLY, THE BRAIN HAS BEEN DAMAGED BUT THE CONTUSION IS NOT FOUND ON THE SCAN. THE PATIENT MUST HAVE AN MRI SOON. THIS WAS THE FIRST TIME THE DEVICE WAS USED. IT WAS REPORTED THAT THE BONE QUALITY WAS NORMAL AND THE DEVICE WAS HELP PERPENDICULAR TO THE BONY SURFACE DURING USE.

  Patient problems: Tissue Damage

  MAUDE report 7718438 ↗