CODMANRecalls & reported problems across all models

We found 54 models of CODMAN by Integra Lifesciences Production Corporation in the FDA's device registry (GUDID). Together they are named in 353 adverse event reports in the FDA's MAUDE database, received between Apr 1, 2021 and Mar 17, 2026 — classified as 111 injuries, 242 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (136 reports).

31 FDA recall records name at least one of these models by its device identifier, 28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CODMAN recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 26, 2025Class IOpen, 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 · Recall details · FDA record ↗

2. Sep 26, 2025Class IOpen, 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-0373-2026 · Root cause: Process change control · Recall details · FDA record ↗

3. Apr 11, 2025Class IOpen, Classified

   Inadequate weld that can potentially cause the product to disassemble.

   Z-1717-2025 · Root cause: Process control · Recall details · FDA record ↗

4. Apr 11, 2025Class IOpen, Classified

   Inadequate weld that can potentially cause the product to disassemble.

   Z-1716-2025 · Root cause: Process control · Recall details · FDA record ↗

5. Sep 20, 2024Class IIOpen, Classified

   Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

   Z-0256-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

6. Sep 20, 2024Class IIOpen, Classified

   Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

   Z-0255-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

7. Sep 20, 2024Class IIOpen, Classified

   Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

   Z-0254-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

8. Sep 20, 2024Class IIOpen, Classified

   Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

   Z-0253-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

9. Sep 20, 2024Class IIOpen, Classified

   Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

   Z-0252-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

10. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0251-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

11. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0250-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

12. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0249-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

13. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0248-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

14. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0247-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

15. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0246-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

16. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0245-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

17. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0244-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

18. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0243-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

19. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0242-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

20. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0241-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

21. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0240-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

22. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0239-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

23. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0238-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

24. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0237-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

25. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0236-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

26. Sep 20, 2024Class IIOpen, Classified

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    Z-0235-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

27. Apr 11, 2023Class IIOpen, Classified

    Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

    Z-1614-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

28. Dec 2, 2022Class IIOpen, Classified

    Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

    Z-0909-2023 · Root cause: Process control · Recall details · FDA record ↗

29. Jan 21, 2022Class IITerminated

    Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

    Z-0818-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

30. Jan 21, 2022Class IITerminated

    Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

    Z-0817-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

…and 1 older recalls, listed on each model's page.

Most reported CODMAN problems

CODMAN models

54 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CODMAN® 261221

  DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
  1 recall223 reports
• CODMAN® 801400

  Neurosurgical paddie
  2 recalls9 reports
• CODMAN® 261222

  DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
  1 recall7 reports
• CODMAN® 801407

  Neurosurgical paddie
  1 recall6 reports
• CODMAN® 801451

  Neurosurgical paddie
  1 recall5 reports
• CODMAN® 201037

  CLIP, SCALP
  1 recall4 reports
• CODMAN® 801404

  Neurosurgical paddie
  1 recall4 reports
• CODMAN® 261230

  DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
  1 recall3 reports
• CODMAN® 261223

  DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
  1 recall2 reports
• CODMAN® 801403

  Neurosurgical paddie
  1 recall2 reports
• CODMAN® 801406

  Neurosurgical paddie
  1 recall2 reports
• CODMAN® 801408

  Neurosurgical paddie
  1 recall2 reports
• CODMAN® 826607

  Device, monitoring, intracranial pressure
  1 recall2 reports
• CODMAN® 801399

  Neurosurgical paddie
  1 recall1 report
• CODMAN® 801401

  Neurosurgical paddie
  1 recall1 report
• CODMAN® 801402

  Neurosurgical paddie
  1 recall1 report
• CODMAN® 801454

  Neurosurgical paddie
  1 recall1 report
• CODMAN® 801455

  Neurosurgical paddie
  1 recall1 report
• CODMAN® 801457

  Neurosurgical paddie
  1 recall1 report
• CODMAN® 826614

  Device, monitoring, intracranial pressure
  1 recall1 report
• CODMAN® 801396

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801397

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801398

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801409

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801449

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801450

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801452

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801453

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 801456

  Neurosurgical paddie
  1 recall0 reports
• CODMAN® 826616

  Device, monitoring, intracranial pressure
  1 recall0 reports
• CODMAN® 823045

  Shunt, central nervous system and components
  13 reports
• CODMAN® 821731C

  Shunt, central nervous system and components
  11 reports
• CODMAN® 245404

  Neurosurgical paddie
  10 reports
• CODMAN® 823041

  Shunt, central nervous system and components
  5 reports
• CODMAN® 901001IRRO

  Electrosurgical, cutting & coagulation & accessories
  5 reports
• CODMAN® 245406

  Neurosurgical paddie
  3 reports
• CODMAN® 821515

  Instrument, shunt system implantation
  3 reports
• CODMAN® 821517

  Instrument, shunt system implantation
  3 reports
• CODMAN® 821735

  Shunt, central nervous system and components
  3 reports
• CODMAN® 245407

  Neurosurgical paddie
  2 reports
• CODMAN® 245412

  Neurosurgical paddie
  2 reports
• CODMAN® 245431

  Neurosurgical paddie
  2 reports
• CODMAN® 824095

  Shunt, central nervous system and components
  2 reports
• CODMAN® 201038

  CLIP, SCALP
  1 report
• CODMAN® 245410

  Neurosurgical paddie
  1 report
• CODMAN® 802902

  Electrosurgical, cutting & coagulation & accessories
  1 report
• CODMAN® 823044

  Shunt, central nervous system and components
  1 report
• CODMAN® 823053

  Shunt, central nervous system and components
  1 report
• CODMAN® 826612

  Device, monitoring, intracranial pressure
  1 report
• CODMAN® 831325

  Instrument, shunt system implantation
  1 report
• CODMAN® 9190002GFB

  Electrosurgical, cutting & coagulation & accessories
  1 report
• CODMAN® 9190002RPB

  Electrosurgical, cutting & coagulation & accessories
  1 report
• CODMAN® 901001CPED

  Electrosurgical, cutting & coagulation & accessories
  1 report
• CODMAN® 901001ESUO

  Electrosurgical, cutting & coagulation & accessories
  1 report

Recent CODMAN adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Excessive Heating

  NA.

  Patient problems: Burn(s)

  MAUDE report 24624225 ↗
• 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 ↗
• InjuryFeb 6, 2026Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 24278013 ↗
• 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 ↗
• InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  NA.

  Patient problems: Insufficient Information

  MAUDE report 23892412 ↗
• InjuryDec 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23782482 ↗
• MalfunctionDec 11, 2025Sparking; Sparking

  A FACILITY REPORTED A DISPOSABLE CODMAN CORD AND TUBING (ID 9190002RPB) SPARKED DURING USE. THE BIPOLAR FORCEPS WERE REMOVED FROM STERILE FIELD, NEW BIPOLAR CORD WAS RETRIEVED, AS WELL AS A NEW GENERATOR. SURGERY WAS CONTINUED AND NO OTHER PROBLEMS WERE NOTED.

  Patient problems: Insufficient Information

  MAUDE report 23782481 ↗
• InjuryNov 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 23617423 ↗
• MalfunctionOct 24, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379906 ↗
• MalfunctionOct 17, 2025Premature Indicator Activation; Premature Indicator Activation

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322780 ↗
• InjuryOct 17, 2025Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23322777 ↗
• 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

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23257896 ↗

Other Integra Lifesciences Production Corporation products

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