CODMAN® 261221Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Disposable Perforator 14mm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Codman disposable perforator has 223 adverse event reports, including 147 malfunctions and 76 injuries, and no deaths. Many reports describe the tool failing to stop during drilling, sometimes damaging the dura or brain. There is 1 open recall, begun in April 2025, over a weld that may let the product come apart. Reports fell from 27 in the prior year to 5 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 223
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 10381780513599), received between May 20, 2021 and Mar 17, 2026 — classified as 76 injuries, 147 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (128 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.
Reports received per month
Recalls naming this device
- Apr 11, 2025Open, Classified
Inadequate weld that can potentially cause the product to disassemble.
Z-1716-2025 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fail-Safe Did Not Operate128
- Material Separation32
- Break29
- Dull, Blunt10
- Insufficient Device Problem Information5
- Mechanical Problem5
- Entrapment of Device4
- Premature Indicator Activation4
Patient problems
- No Clinical Signs, Symptoms or Conditions110
- Brain Injury58
- Insufficient Information45
- Hemorrhage/Blood Loss/Bleeding5
- Laceration(s)3
- Intracranial Hemorrhage2
- Bruise/Contusion1
- Burn(s)1
Recent adverse event reports
The 25 most recent of 223 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Excessive Heating
MalfunctionMar 13, 2026Fail-Safe Did Not Operate
A FACILITY REPORTED A PERFORATOR (ID 261221) FAILED TO DISENGAGE AT PROXIMITY OF THE DURA. ADDITIONAL INFORMATION RECEIVED: - THE MOTOR DID NOT STOP IN TIME AND CONTINUED AFTER DRILLING. - DID THE PROBLEM OCCUR DURING THE FIRST TREPHINE HOLE? YES, THE PROBLEM OCCURRED DURING THE FIRST HOLE. - WAS THE SURGERY TIME INCREASED AS A RESULT OF THIS INCIDENT? YES, THE SURGERY TIME INCREASED BY APPROXIMATELY 10 MINUTES. - DID THE INCIDENT RESULT IN ANY CONSEQUENCES FOR THE PATIENT'S HEALTH? IF SO, WHAT TREATMENT WAS NECESSARY? FORTUNATELY, THE INCIDENT DID NOT RESULT IN SERIOUS CONSEQUENCES; OTHERWISE, THERE WOULD HAVE BEEN A SIGNIFICANT RISK OF A PARIETAL CONTUSION AND THEREFORE PERMANENT HEMIPLEGIA. - WHAT IS THE PATIENT'S CURRENT HEALTH STATUS? THE PATIENT IS THANKFULLY DOING WELL. - WHAT IS THE BRAND OF MOTOR USED WITH THE DRILL? BRAND: MEDTRONIC - IS THE MOTOR ELECTRIC OR PNEUMATIC? ELECTRIC - WAS THE DRILL CORRECTLY ASSEMBLED WITH THE MOTOR? YES, THE DRILL WAS CORRECTLY ASSEMBLED. - WERE THE RECOMMENDED TESTS PERFORMED BETWEEN EACH HOLE? ONLY ONE TREPHINE HOLE WAS DRILLED. - WAS THE APPROACH ANGLE PERPENDICULAR AS INDICATED IN THE OPERATING INSTRUCTIONS? YES, THE ANGLE WAS INDEED PER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593998 ↗InjuryFeb 20, 2026Fail-Safe Did Not Operate
A FACILITY REPORTED A PERFORATOR (ID 261221) DID NOT DISENGAGE, CAUSING WOUNDS IN THE DURA. DUROPLASTY WAS PERFORMED AND THE EVENT LED TO MORE THAN 30 MINUTES SURGICAL DELAY. ACCORDING TO INFORMATION PROVIDED, THE MOTOR USED WITH A PERFORATOR WAS AN ELECTRIC MEDTRONIC MOTOR AND DRILL. THE DRILL WAS CORRECTLY ASSEMBLED WITH THE MOTOR, THE RECOMMENDED TESTS WERE PERFORMED BETWEEN EACH BURR HOLE, THE APPROACH ANGLE WAS PERPENDICULAR WITH CONSTANT DOWNWARD PRESSURE.
Patient problems: Brain Injury
MAUDE report 24400464 ↗MalfunctionJan 21, 2026Fail-Safe Did Not Operate
A NURSE REPORTED A DISPOSABLE PERFORATOR (ID 261221) WAS EITHER USED OR FUNCTIONED INCORRECTLY DURING A BURR HOLE AND PLUNGED INTO THE PATIENT. THE DRILL USED WAS ELECTRIC. THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE WAS PATIENT INJURY. IT IS UNKNOWN IF THE PERFORATOR CLICKED IN PLACE IN THE DRILL. IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 24134516 ↗InjuryJan 21, 2026Fail-Safe Did Not Operate
A PHYSICIAN REPORTED A DISPOSABLE PERFORATOR (ID 261221) FAILED TO STOP AND DAMAGED THE DURA MATER AND THE NONFUNCTIONAL PART OF THE BRAIN. HEMOSTASIS WAS PERFORMED AS AN IMMEDIATE MEASURE TO MANAGE THE PATIENT¿S CONDITION. THERE WAS LESS THAN 30 MINUTES OF SURGICAL DELAY. ACCORDING TO INFORMATION PROVIDED, THE MANUFACTURER OF THE DRILL USED WITH THE PERFORATOR IS UNKNOWN. 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 BEING PERFORMED BETWEEN EACH BURR HOLE. THREE BURR HOLES WERE COMPLETED BEFORE THE PERFORATOR MALFUNCTIONED. IT IS UNKNOWN IF THERE HAVE BEEN RECENT CHANGES WITH THE DRILL AND WITH THE DRIVER. IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS COMPLETED.
Patient problems: Brain Injury
MAUDE report 24133371 ↗MalfunctionOct 24, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
MalfunctionOct 17, 2025Premature Indicator Activation; Premature Indicator Activation
MalfunctionOct 10, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
A FACILITY REPORTED A PERFORATOR (ID 261221) DOESN'T STOP ONCE IT LOSES RESISTANCE. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23266833 ↗MalfunctionOct 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionSep 5, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
MalfunctionSep 5, 2025Premature Activation; Fail-Safe Did Not Operate; Premature Activation; Fail-Safe Did Not Operate
2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3014334038-2025-00122 3014334038-2025-00124. A FACILITY REPORTED: "A PERFORATOR (ID 261221) DOES NOT LOCK OR DISENGAGE AUTOMATICALLY AFTER DRILLING THROUGH THE OUTER ONLY, AS EXPECTED. IT SHOULD LOCK ONCE THE OUTER HAS BEEN DRILLED TO PREVENT FURTHER ADVANCEMENT AND PROTECT UNDERLYING STRUCTURES." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 22978144 ↗MalfunctionSep 5, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3014334038-2025-00123. 3014334038-2025-00124. A FACILITY REPORTED: "A PERFORATOR (ID (B)(6)) DOES NOT LOCK OR DISENGAGE AUTOMATICALLY AFTER DRILLING THROUGH THE OUTER ONLY, AS EXPECTED. IT SHOULD LOCK ONCE THE OUTER HAS BEEN DRILLED TO PREVENT FURTHER ADVANCEMENT AND PROTECT UNDERLYING STRUCTURES." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 22978143 ↗MalfunctionAug 28, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
InjuryAug 28, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
InjuryAug 8, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
A FACILITY REPORTED THAT A CODMAN PERFORATOR (ID 261221) FAILED TO STOP ROTATING AFTER PENETRATING THE SKULL. THE DEVICE CONTINUED SPINNING UPON CONTACT WITH THE DURA MATER, RESULTING IN A DURA TEAR AND SIGNIFICANT BLOOD LOSS IN THE PATIENT. A SURGICAL DELAY WAS REPORTED (UNKNOWN FOR HOW LONG); HOWEVER, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AFTER SEVERAL ATTEMPTS.
Patient problems: Brain Injury
MAUDE report 22748741 ↗MalfunctionJul 31, 2025Premature Indicator Activation; Premature Indicator Activation
LINKED TO MFG REPORT NUMBERS: 3014334038-2025-00077, 3014334038-2025-00078, 3014334038-2025-00109, 3014334038-2025-00080. A FACILITY REPORTED A PERFORATOR (ID 261221) STOPPED BEFORE COMPLETING THE TREPANATION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY/CONSEQUENCES REPORTED; HOWEVER, THE EVENT LED TO 30 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22677265 ↗MalfunctionJul 31, 2025Premature Indicator Activation; Premature Indicator Activation
A FACILITY REPORTED A PERFORATOR (ID 261221) STOPPED BEFORE COMPLETING THE TREPANATION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY/CONSEQUENCES REPORTED; HOWEVER, THE EVENT LED TO 30 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22677261 ↗InjuryJul 16, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
A PHYSICIAN REPORTED THAT WHILE USING A CODMAN PERFORATOR (ID 261221) TO CREATE THE THIRD BURR HOLE DURING A CONVEXITY MENINGIOMA RESECTION, THE DEVICE¿S AUTO-RELEASE FUNCTION DID NOT OPERATE PROPERLY. ACCORDING TO THE PHYSICIAN, THERE WAS NO DURAL DEFECT AND NO INDICATION OF BRAIN CONTUSION. HOWEVER, SIGNIFICANT BLEEDING OCCURRED FROM THE SUPERIOR SAGITTAL SINUS (SSS), WHICH THE PHYSICIAN WAS ABLE TO CONTROL. THE INCIDENT RESULTED IN A SURGICAL DELAY OF MORE THAN 30 MINUTES. THE PATIENT IS FOR FOLLOW-UP. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE DRILL WAS ELECTRIC OR PNEUMATIC. IT IS ALSO UNKNOWN IF THE PERFORATOR CLICKED INTO PLACE IN THE DRILL, AND IF THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE. IT IS UNKNOWN IF A PERPENDICULAR APPROACH WAS MAINTAINED THROUGH THE DRILLING PROCESS OR WAS THERE ANY ROCKING MOTION INCLUDED. IT IS ALSO UNKNOWN IF THERE WAS CONSTANT DOWNWARD PRESSURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22520710 ↗MalfunctionJun 13, 2025Premature Indicator Activation; Premature Indicator Activation
MalfunctionJun 13, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
A FACILITY REPORTED A PERFORATOR ((ID 261221) DIDN'T STOP AND PASSED THROUGH THE SECOND CORTEX. NO PATIENT INJURY/CONSEQUENCES REPORTED; HOWEVER, THE EVENT LED TO ONE HOUR SURGICAL DELAY DUE TO PRODUCT PROBLEM. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202056 ↗MalfunctionMay 7, 2025Material Separation; Material Separation
A FACILITY REPORTED THAT, DURING THE ATTEMPT TO USE THE CODMAN PERFORATOR (ID (B)(6) FOR TREPANATION, THE METAL PART DETACHED FROM THE BLUE PART. THE CRANIOTOMY WAS THEN CONTINUED USING A CHISEL AND HAMMER, AND THE EVENT LED TO 30 MINUTES SURGICAL DELAY. NO PATIENT INJURY REPORTED. THE DRILL USED WAS A SKILL BRAND ELECTRIC DRILL. THE PERFORATOR CLICKED IN PLACE WITH THE DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21976879 ↗MalfunctionApr 30, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
A FACILITY REPORTED A DISPOSABLE PERFORATOR (ID 261221) DISENGAGED PRIOR TO COMPLETING THE FULL DEPTH OF THE DRILL, REQUIRING SURGEON TO COMPLETE ENTRY FOR SKULL-BASED PROCEDURE WITH OTHER OPTIONS. THE EVENT LED TO 20-30 MINUTES SURGICAL DELAY WITH NO PATIENT CONSEQUENCES. THE DRILL USED WITH THE PERFORATOR WAS PNEUMATIC STRYKER. THE PERFORATOR CLICKED IN PLACE IN THE DRILL, AND THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE. THERE WAS A CONSTANT DOWNWARD PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934223 ↗MalfunctionApr 4, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
MalfunctionMar 21, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
InjuryFeb 27, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
Other DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) devices
- Zyphr 5100060001Stryker Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)1 recall199 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAAMicromar Indústria e Comércio Ltda · Drills, Burrs, Trephines & Accessories (Compound, Powered)67 reports
- CODMAN® 261222Integra Lifesciences Production Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)1 recall7 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAAMicromar Indústria e Comércio Ltda · Drills, Burrs, Trephines & Accessories (Compound, Powered)54 reports
- CODMAN® 261230Integra Lifesciences Production Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)1 recall3 reports
- CODMAN® 261223Integra Lifesciences Production Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)1 recall2 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAAMicromar Indústria e Comércio Ltda · Drills, Burrs, Trephines & Accessories (Compound, Powered)37 reports
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAAMicromar Indústria e Comércio Ltda · Drills, Burrs, Trephines & Accessories (Compound, Powered)31 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.