This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
| Product Name | Unique Device Identifier (UDI) |
|---|---|
| Codman Disposable Perforator 14 mm | 10381780513599 |
| Codman Craniotomy Kit Containing Disposable Perforator 14 mm, Cranio-blade, Wire Pass Drill | 10381780513629 |
Lot/Serial Numbers: Full List of Affected Lots
What to Do:
- Stop using and immediately quarantine all affected products.
- Review inventory and identify affected lot numbers using the provided lot list.
On April 11, 2025, Integra LifeSciences sent all affected customers an Urgent Medical Device Recall Notification recommending the following actions:
- Stop using and quarantine all affected product immediately.
- Review your inventory and identify impacted lot numbers.
- Complete and return the appropriate Acknowledgement Form to Integra via email at FCA3@integralife.com or fax to 1-609-750-4220.
- Notify all appropriate clinical or distribution staff.
- Return affected product after receiving a Return Material Authorization (RMA). Credit will be provided for returned affected lots.
Reason for Recall
Integra LifeSciences is recalling specific Codman Disposable Perforators and Craniotomy Kits due to an inadequate ultrasonic weld (a “proud weld”) on the outer sleeve of the device. This weld defect may cause the perforator to disassemble before, during, or after use in craniotomy procedures. In some cases, the device may fail to disengage, preventing the device from stopping immediately.
The use of affected product may cause serious adverse health consequences, including damage to the dura, bleeding, brain injury, extended surgery, irreversible brain damage, and death.
There have been 10 reported injuries including those from procedural delay, device becoming lodged in the patient’s skull during use, difficulty removing device fragments, bleeding, dural injury, and cerebral injury. There have been no reports of death.
Device Use
Codman Disposable Perforators are single-use surgical tools used in neurosurgical procedures to drill access holes into the skull. They are designed to automatically disengage once drilling is complete.
Contact Information
Customers in the U.S. with questions about this recall should contact Integra LifeSciences at 1-800-654-2873.
Additional FDA Resources (listed in order of most to least recent):
FDA’s Enforcement Report:
Medical Device Recall Database:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
