CODMAN® 826612Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Cranial Access Kit · Class 2
All models of CODMAN (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780520368), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K914479); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED A CRANIAL ACCESS KIT (ID 826612) WAS USED TO PLACE AN EXTERNAL VENTRICULAR DRAINAGE (EVD). ON MULTIPLE OCCASIONS, THE SURGEONS FEEL LIKE THE DRILL BIT GOT DULL AND THEY HAD TO OPEN ANOTHER KIT TO COMPLETE THE PROCEDURE. THEY SPECIFICALLY SAID THAT, AFTER THEY WOULD GET THROUGH THE ¿OUTER TABLE¿ THEY FELT LIKE THE DRILL WAS NOT ABLE TO GET THROUGH THE ¿INNER TABLE.¿ NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18950842 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K914479. One submission often covers many models, so check the product and lot details in each record.
- Z-1614-2023 · Apr 11, 2023 · Open, ClassifiedCodman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Par
- Z-0706-2012 · Oct 25, 2011 · TerminatedCodman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xy
- Z-0707-2012 · Oct 25, 2011 · TerminatedCodman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and th
Other Device, monitoring, intracranial pressure devices
- Exacta™ 27666Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall124 reports
- Exacta™ 46705Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall117 reports
- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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