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If you or someone close to you underwent brain surgery and are now facing unexpected health complications, it may be linked to a faulty surgical device used during the procedure. You’re not alone — and you deserve answers.
Integra LifeSciences has recalled thousands of its Codman Disposable Perforators, also known as cranial drills. These tools are used in brain surgeries to drill holes in the skull, but a defect in the product has caused them to break apart during surgery.
The U.S. Food and Drug Administration (FDA) labeled this a Class I product recall lawsuit, meaning the device could cause serious injury or even death. Patients who were harmed may be able to file an Integra cranial drill recall lawsuit to seek compensation.
Summary of the Integra Cranial Drill Recall
The Codman Disposable Perforator is designed to stop automatically after drilling into the skull. But Integra found that a welding issue could cause the device to break apart or keep spinning during use.
In April 2025, the company told hospitals to stop using and return the affected drills. At least 10 people were seriously hurt during surgery. Problems included bleeding, brain damage, and broken drill pieces getting stuck in the skull.
What Went Wrong?
The Codman Disposable Perforator was designed to stop automatically after drilling through the skull, helping surgeons avoid damage to the brain. But a manufacturing defect, a faulty ultrasonic weld, caused some units to disassemble or fail to stop.
When this happened, sharp pieces of the device sometimes broke off and became lodged in the skull. In other cases, the drill continued spinning, increasing the risk of tearing the dura (the brain’s protective covering), damaging brain tissue, or causing dangerous bleeding. Instead of supporting a safe and predictable surgery, the defective devices turned routine procedures into high-risk situations.
Known Injuries and Side Effects
The recalled Integra cranial drills have caused serious harm during what should have been routine brain surgeries. Reported injuries include bleeding inside the skull, damage to the brain or the protective dura mater layer, and broken pieces of the drill being left behind. Injuries caused by a brain injury recalled medical device can lead to permanent disability and lifelong health complications.
In some cases, patients required additional procedures to remove lodged fragments or address new neurological issues caused by the malfunction. These types of injuries can result in long-term disability, cognitive problems, and a lifetime of medical care. If you or a loved one experienced complications after surgery involving this device, it’s important to speak with a cranial drill defect injury attorney. They can help you determine if you’re eligible to file a claim and seek compensation.
Who Qualifies for the Integra Cranial Drill Lawsuit?
You may be eligible to file a Codman cranial perforator lawsuit if:
- You had brain surgery between 2021 and 2025
- The recalled Integra device may have been used
- You experienced problems during or after the procedure, like bleeding, infection, or neurological issues
- You needed another surgery to correct a complication
Hospitals across the U.S. used these drills, so even if you don’t know which brand was used, we can help investigate.
FDA Timeline and Recall Details
The FDA flagged safety concerns about these devices long before the recall was officially issued. In 2023, the agency issued warning letters and Form 483 reports after finding that several Integra manufacturing facilities were not complying with required safety standards. These facilities made the same cranial drills that would later be recalled.
In 2024, Integra recalled over 170,000 units of the Codman Disposable Perforator and nearly 2,000 units of a craniotomy kit that contained the device. The FDA then classified the recall as Class I, the most serious level, due to the potential for severe injury or death. This timeline shows that problems were building for months, possibly even years, before corrective action was taken.
What Legal Action Can Be Taken?
Filing a lawsuit can help you recover the financial costs of your injury, including hospital bills, additional surgeries, lost wages, and long-term care. But it’s also about holding Integra accountable. Patients trusted this medical device to work safely during life-changing procedures. When that trust was broken, the consequences were devastating.
Our attorneys work with medical experts and product engineers to build strong cases. Even if you’re not sure whether you qualify, we can review your records and help you understand your options. There are no upfront costs, and we don’t get paid unless we win compensation for you.
Our Experience With Medical Device Cases
At Lytal, Reiter, Smith, Ivey & Fronrath, we’ve helped people across the country who were hurt by dangerous medical products. We understand how to handle complex cases like this one, and we work with top experts to prove exactly how and why a product failed.
We’re not afraid to take on large manufacturers. Our attorneys have successfully handled cases involving defective surgical tools, implants, and other recalled devices, and we’re ready to help you, too.
Contact Our Product Recall Attorneys Today
If you or a loved one suffered a brain injury, prolonged surgery, or other serious harm from an Integra cranial drill, you may be eligible to take legal action. At Lytal, Reiter, Smith, Ivey & Fronrath, we’re actively investigating product recall cases nationwide and have decades of experience holding medical device manufacturers accountable.
Call our team at (561) 655-1990 or send us a message to schedule your free consultation. We’ll listen to your story and help you understand whether you qualify for compensation. There’s no cost to speak with us, and we only get paid if we win your case.
Don’t wait; your time to file may be limited. Let us help you get the justice and support you deserve.
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FAQ: Integra Lifesciences Cranial Drill Recall
How do I find out if the recalled Integra drill was used in my surgery?
Start by requesting a copy of your surgical or hospital records. These records should list the specific devices used during the procedure. But if you’re unsure how to obtain them or what to look for, an Integra Lifesciences recall lawyer can help investigate on your behalf.
Can I sue if I don’t have the drill or packaging?
Yes. Most patients never see the surgical tools used during their procedures. You don’t need to have the physical product to file a claim. Medical records and imaging scans can help confirm the use of the recalled drill and prove the harm it caused.
What if I didn’t have complications right away?
Injuries caused by defective surgical tools might not be obvious at first. Some people develop symptoms, like chronic headaches, neurological issues, or the need for revision surgery, months later. If you’re now experiencing health problems after brain surgery, it’s worth exploring if the recalled device may be to blame.
Can I still sue Integra Lifesciences if the surgery happened years ago?
Possibly. Each state has a time limit (called a statute of limitations) for filing injury claims, but that clock may not start until you discover the injury or the recall. If you only recently learned about the defect or connected it to your health problems, you may still have time to take legal action. Talk with an experienced product recall attorney if you’re unsure.
