CODMANRecalls & reported problems across all models

We found 41 models of CODMAN by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2017 and Apr 1, 2025 — classified as 2 deaths, 56 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (11 reports).

22 FDA recall records name at least one of these models by its device identifier, 22 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 20, 2024Open, 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 ↗

2. Sep 20, 2024Open, 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 ↗

3. Sep 20, 2024Open, 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 ↗

4. Sep 20, 2024Open, 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 ↗

5. Sep 20, 2024Open, 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 ↗

6. Sep 20, 2024Open, 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 ↗

7. Sep 20, 2024Open, 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 ↗

8. Sep 20, 2024Open, 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 ↗

9. Sep 20, 2024Open, 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 ↗

10. Sep 20, 2024Open, 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 ↗

11. Sep 20, 2024Open, 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 ↗

12. Sep 20, 2024Open, 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 ↗

13. Sep 20, 2024Open, 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 ↗

14. Sep 20, 2024Open, 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 ↗

15. Sep 20, 2024Open, 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 ↗

16. Sep 20, 2024Open, 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 ↗

17. Sep 20, 2024Open, 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 ↗

18. Sep 20, 2024Open, 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 ↗

19. Sep 20, 2024Open, 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 ↗

20. Sep 20, 2024Open, 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 ↗

21. Sep 20, 2024Open, 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 ↗

22. Sep 20, 2024Open, 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 ↗

Most reported CODMAN problems

CODMAN models

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

• CODMAN 80-1407

  NEUROSURGICAL PADDIE
  1 recall2 reports
• CODMAN 80-1399

  NEUROSURGICAL PADDIE
  1 recall1 report
• CODMAN 80-1403

  NEUROSURGICAL PADDIE
  1 recall1 report
• CODMAN 80-1408

  NEUROSURGICAL PADDIE
  1 recall1 report
• CODMAN 80-1396

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1397

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1398

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1400

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1401

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1402

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1404

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1406

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1409

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1449

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1450

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1451

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1452

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1453

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1454

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1455

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1456

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN 80-1457

  NEUROSURGICAL PADDIE
  1 recall0 reports
• CODMAN AP-03000H

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 deaths32 reports
• CODMAN 26-1221

  DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
  21 reports
• CODMAN AP-03000L

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  17 reports
• CODMAN 82-1707

  Shunt, central nervous system and components
  9 reports
• CODMAN 82-1706

  Shunt, central nervous system and components
  3 reports
• CODMAN AP-03000M

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  3 reports
• CODMAN 26-1222

  DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
  2 reports
• CODMAN AP-03000UL

  PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 reports
• Codman 901001IRRO

  Electrosurgical, cutting & coagulation & accessories
  2 reports
• CODMAN 20-1037

  CLIP, SCALP
  2 reports
• CODMAN 26-1223

  DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
  1 report
• CODMAN 82-1705

  Shunt, central nervous system and components
  1 report
• CODMAN 82-1739

  Shunt, central nervous system and components
  1 report
• CODMAN 80-2985

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 report
• CODMAN 24-5404

  NEUROSURGICAL PADDIE
  1 report
• CODMAN 24-5405

  NEUROSURGICAL PADDIE
  1 report
• CODMAN 24-5407

  NEUROSURGICAL PADDIE
  1 report
• CODMAN 24-5408

  NEUROSURGICAL PADDIE
  1 report
• CODMAN 24-5411

  NEUROSURGICAL PADDIE
  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.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERA ONCOLOGY RECEIVED A REPORT OF A REVISION THAT WAS PERFORMED. THE REVISION WAS DUE TO THE PATIENT DEVELOPING A PSEUDOANEURYSM OF HER COMMON HEPATIC ARTERY AND REQUIRING A STENT. THE PHYSICIAN ATTACHED A TAPERED CATHETER TO THE ALREADY IMPLANTED HEPATIC ARTERY INFUSION PUMP AND INSERTED CATHETER INTO THE SPLENIC ARTERY. NO NEW PUMP WAS IMPLANTED. THE PHYSICIAN REPORTED EVERYTHING WENT WELL.

  Patient problems: Pseudoaneurysm

  MAUDE report 21743152 ↗
• 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 ↗
• MalfunctionOct 18, 2024Obstruction of Flow; Obstruction of Flow

  INTERA ONCOLOGY, RECEIVED A REPORT FROM CLINIC OF HIGH RESIDUALS OF GLYCERIN IN THE PUMP. THE CLINIC ORIGINALLY DISPENSED 30ML OF GLYCERIN TO THE PUMP. ON (B)(6) 2024, ON THE PATIENT'S SCHEDULED 6 WEEK GLYCEROL FLUSH, THE CLINIC FLUSHED 26ML OF RESIDUAL. THE GLYCERIN LOT NUMBER THE CLINIC USED WAS 0004605665 AND THE EXPIRATION DATE WAS OCTOBER 2026. THIS LOT WAS MANUFACTURED BY ALK LABORATORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486849 ↗
• MalfunctionOct 18, 2024Obstruction of Flow; Obstruction of Flow

  INTERA ONCOLOGY, RECEIVED A REPORT FROM CLINIC OF HIGH RESIDUALS OF GLYCERIN IN THE PUMP. THE CLINIC ORIGINALLY DISPENSED 30ML OF GLYCERIN TO THE PUMP. ON (B)(6) 2024, ON THE PATIENT'S SCHEDULED 9 WEEK GLYCEROL FLUSH, THE CLINIC FLUSHED 30 ML OF RESIDUAL. THE CLINIC COMPLETED FLOW STUDY ON (B)(6) 2024 AND NO OBSTRUCTION WAS FOUND. THE GLYCERIN LOT NUMBER THE CLINIC USED WAS 0004605665 AND THE EXPIRATION DATE WAS OCTOBER 2027. THIS LOT WAS MANUFACTURED BY ALK LABORATORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486781 ↗
• MalfunctionOct 4, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 20369178 ↗
• InjuryNov 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REPORT: VERHEIJ FS, KUHLMANN KFD, SILLIMAN DR, SOARES KC, KINGHAM TP, BALACHANDRAN VP, DREBIN JA, WEI AC, JARNAGIN WR, CERCEK A, KOK NFM, KEMENY NE, D'ANGELICA MI. COMBINED HEPATIC ARTERIAL INFUSION PUMP AND SYSTEMIC CHEMOTHERAPY IN THE MODERN ERA FOR CHEMOTHERAPY-NAIVE PATIENTS WITH UNRESECTABLE COLORECTAL LIVER METASTASES. ANN SURG ONCOL. 2023 AUG 28. DOI: 10.1245/S10434-023-14073-3. EPUB AHEAD OF PRINT. PMID: 37639032. THE LITERATURE SOURCE REPORTED A RETROSPECTIVE STUDY OF FIFTY-EIGHT CHEMOTHERAPY-NAIVE PATIENTS WERE IDENTIFIED OUT OF 546 PATIENTS WITH UNRESECTABLE CRLM (COLORECTAL LIVER METASTASES) MANAGED WITH HAI BETWEEN 2003 AND 2019. THE FOLLOWING ADVERSE EVENTS WERE REPORTED IN THIS STUDY: SURGICAL SITE INFECTION, ANASTOMOTIC LEAK (INTESTINAL), ILEUS (PARALYTIC), PUMP-RELATED INFECTION, FEVER.

  Patient problems: Fever; Obstruction/Occlusion; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18117404 ↗
• 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 ↗
• InjuryAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS DISCUSSED WITH VARIOUS OFFICIALS AT A HEALTHCARE PROVIDER THAT AN ADVERSE EVENT MAY HAVE OCCURRED WITH THE USE OF A CODMAN 3000 HIGH FLOW INFUSION PUMP. IMPLANT DATE WAS (B)(6) 2018. THE SURGEON WHO EXPLANTED THE DEVICE STATED TO INTERA THAT THE DEVICE WAS EXPLANTED DUE TO 'CONCERN FOR INFECTION.' ADDITIONAL CONVERSATIONS WITH THE PROVIDER STATED THAT THE CLINICAL NOTES WERE 'UNCLEAR,' BUT THERE ALSO APPEARED TO BE A POSSIBLE EXTRAVASATION EVENT. THEREFORE, THE HEALTHCARE PROVIDER REQUESTED A DEVICE EVALUATION TO DETERMINE IF A MALFUNCTION HAD OCCURED OR NOT. THE EXTRAVASATION EVENT WAS REPORTED TO BE 04/18/2023. EXPLANT DATE WAS REPORTED TO BE (B)(6) 2023. IT WAS REPORTED THAT THE MITOMYCIN AND FUDR (FLOXURIDINE) WERE INFUSED AT THE TIME OF THE EVENT.

  Patient problems: Extravasation

  MAUDE report 17577746 ↗
• MalfunctionAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT RETURNED A CARD FROM THE JUNE 2023 ROUTINE IMPLANT TRACKING MAILING STATING THE FOLLOWING: "PUMP HAS NOT BEEN REMOVED BUT DOES NOT WORK." NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17577202 ↗
• InjuryAug 4, 2023Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  CITATION: GUI M., SEHGAL N. 2023. SYMPTOMATIC INTRATHECAL CATHETER TIP GRANULOMA FORMATION WITH ULTRALOW-DOSE AND LOW-CONCENTRATION MORPHINE INFUSION: A CASE REPORT AND REVIEW OF LITERATURE. NEUROMODULATION JUN 27 2023; 1-7. DOI:HTTPS://DOI.ORG/10.1016/J. IT WAS REPORTED THAT A 55-YEAR-OLD MALE PATIENT WITH L5-S1 FUSION AND CHRONIC LUMBOSACRAL RADICULOPATHY REPORTED NUMBNESS AND WEAKNESS IN BOTH LOWER LIMBS DURING ROUTINE PUMP REFILL VISITS. HE HAD A NON-PROGRAMMABLE, CONSTANT-FLOW (0.5ML/D) CODMAN®3000 PAIN PUMP IMPLANTED 5 YEARS PRIOR FOR PAIN MANAGEMENT. THE PATIENT INITIALLY PRESENTED FOR CHRONIC LOW BACK PAIN WITH MULTIPLE LUMBAR SPINE SURGERIES, INCLUDING RECENT L5-S1ANTERIOR AND POSTERIOR SPINAL FUSION COMPLICATED BY STAPHYLOCOCCUS AUREUS SURGICAL SITE INFECTION. AT THE TIME OF INITIAL EVALUATION FOR PUMP IMPLANT, THERE WERE PERMANENT BUT STABLE SENSORY MOTOR DEFICITS IN THE LOWER LIMBS ON BASELINE NEUROLOGIC EXAMINATION. NO COMPLICATIONS WERE NOTED AT THE TIME OF PUMP PLACEMENT WITH CATHETER IN SUBARACHNOID SPACE AT T10. A CODMAN®3000 PAIN PUMP WITH FLEXITIP PLUS, 19-GAUGE, CODMAN CATHETER (CLOSED END, FENESTRATED, MEDICAL GRADE SILICONE IMPREGNATED WITH BARIUM SULFATE ) WA

  Patient problems: Balance Problems; Granuloma; Numbness

  MAUDE report 17463453 ↗
• InjuryJul 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED THE CLINICAL CALL LINE IN RESPONSE TO JUNE 2023 MAILING. THE MESSAGE FROM THE CCL WAS "HE IS THE PATIENT. VERY ANGRY HE RECEIVED THIS NOTICE SINCE YOU SHOULD KNOW WHERE THE PUMP IS ALREADY YOURSELF AND ANGRY THAT THE 'PUMP ALMOST KILLED HIM.'"

  Patient problems: Insufficient Information

  MAUDE report 17367335 ↗
• MalfunctionJun 9, 2023Component Missing; Component Missing

  A FACILITY REPORTED A SURGICAL PATTIE (ID 245404) WAS NOTED TO BE MISSING THE BLUE STRIP AND WAS UNABLE TO BE FOUND. AFTER GETTING ALL 10 PATTIES OFF THE FIELD, ONE PATTIE WAS NOTED TO BE MISSING THE BLUE STRIP AND WAS UNABLE TO BE FOUND. THE EVENT DID NOT LEAD TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097969 ↗
• MalfunctionMay 17, 2023Separation Problem; Separation Problem

  A FACILITY REPORTED A SURGICAL PATTY (ID 801399) WAS PLACED IN SITU ON THE BRAIN. HOWEVER, WHEN SURGEON WENT TO REMOVE PATTY BY PULLING THE STRING, THE STRING CAME AWAY AND LEFT THE PATTY IN SITU. THE PATTY WAS REMOVED FROM BRAIN AFTER IT WAS NOTICED TO BE STILL IN SITU AFTER PULLING THE STRING OFF. WHEN THE PATTY WAS PLACED ON THE BRAIN IT WAS NOT MOISTENED AS IT WAS ALREADY IN SITU TO ABSORB BLOOD. THE PATTIES WERE MOISTENED WITH RINGERS SOLUTION WITHIN 5 MINUTES PRIOR TO USE. IT WAS NOT ALTERED OR CUT FROM THE ORIGINAL SIZE PRIOR TO USE, AND NO DELAY OF THE PROCEDURE WAS REPORTED. SURGICAL PROCEDURE: RETRO SIGMOID REPAIR OF RIGHT MASTOID ENCEPHALOCELE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946524 ↗
• InjuryMar 9, 2023Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515868 ↗
• 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 ↗

Other Cerenovus, Inc. products

• GALAXY G358 models · 1,386 reports · 1 recall
• MICRUSFRAME47 models · 298 reports
• DELTAFILL29 models · 294 reports
• CEREPAK FREEFORM60 models · 166 reports · 1 recall
• CEREBASE3 models · 143 reports · 1 recall
• DELTAXSFT13 models · 130 reports
• CEREPAK UNIFORM58 models · 33 reports · 1 recall
• CEREGLIDE6 models · 70 reports