Defective cranial drills issued by Integra lead to 10 reported injuries, prompting a product recall
Integra Lifesciences, a leading medical device company, has initiated a recall of its Codman Disposable Perforators and Craniotomy Kits in April 2025. The recall is due to an inadequate ultrasonic weld, known as a "proud weld," on the device's outer sleeve, which may cause the perforator to disassemble before, during, or after use in craniotomy surgeries or fail to automatically disengage[1][3].
The recall involves over 170,000 recalled units, including about 1,850 craniotomy kits distributed by Medline containing the affected 14mm perforators[2][4]. The device is single-use, designed to drill access holes in the skull and automatically disengage once drilling is complete[1][3].
The defect has resulted in 10 reported injuries but no deaths. Reported adverse events include procedural delays, device lodging in the skull, difficulty removing device fragments, bleeding, dural (brain membrane) injury, and cerebral injury[1][2][3].
The Food and Drug Administration (FDA) has classified this as a Class I recall—the highest risk level—and supports urgent actions by Integra and Medline to quarantine, label, and remove affected products from use[1][2]. Medline issued a correction advising customers to remove the faulty perforators from craniotomy kits before use[4].
The FDA has entered five Class I recall entries in its database, covering Integra recalls of 170,510 units of its disposable cranial perforator and 1,840 units of a craniotomy kit that contains the affected device[2]. The FDA has also entered recall entries for Medline Industries' recalls of craniotomy kits that contain the cranial perforator.
Integra identified additional ship holds for certain products at its Codman and tissue businesses late in the first quarter[5]. The company has asked customers to quarantine and return affected devices[4].
Integra Lifesciences received Form 483s last year from the FDA, indicating devices including cranial perforators were noncompliant with quality system regulations[6]. The FDA sent a warning letter to Integra in relation to problems described in the Form 483s, later in 2024[6].
No publicly available FDA warning letter has been found associated with this recall based on the current search results. The recall notices emphasize product quarantine and return rather than regulatory enforcement letters[1][2][4].
For questions, Integra LifeSciences can be contacted at 1-800-654-2873, and Medline’s Recall Department at 866-359-1704 or [email protected][1][4]. The FDA’s recall database has official documentation of this event[1].
[1] FDA Recall Database: https://www.fda.gov/safety/recalls/ [2] Medline Recall Notice: https://www.medline.com/recall-notice-for-codman-disposable-perforator-14mm-craniotomy-kits-distributed-by-medline [3] Integra Lifesciences Recall Notice: https://www.fda.gov/medical-devices/safety-communications/safety-communication-integra-lifesciences-corp-cranial-perforator-recall [4] Medline Correction Notice: https://www.medline.com/correction-notice-for-codman-disposable-perforator-14mm-craniotomy-kits-distributed-by-medline [5] Integra Lifesciences Earnings Call Transcript: https://seekingalpha.com/transcript/661713-integra-lifesciences-corp-q4-2024-earnings-call-transcript [6] FDA Form 483: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-reports-and-compliance-evaluations/form-483
- The recall of Integra Lifesciences' Codman Disposable Perforators and Craniotomy Kits, initiated in April 2025, involves over 170,000 units due to a "proud weld" defect that may cause the device to disassemble.
- The Food and Drug Administration (FDA) has classified this recall as a Class I recall, the highest risk level, urging immediate actions by Integra and Medline.
- Medline, a distributor of the affected craniotomy kits, has advised customers to remove the faulty perforators before use.
- The FDA has entered recall entries for both Integra and Medline, covering nearly 172,000 units in total.
- Integra has identified additional ship holds for certain products and has asked customers to quarantine and return affected devices.
- Last year, Integra received Form 483s from the FDA, indicating devices including cranial perforators were noncompliant with quality system regulations.
- The FDA sent a warning letter to Integra in relation to problems described in the Form 483s, but no publicly available FDA warning letter has been found associated with this recall.
- Patients or healthcare professionals with questions related to this recall can contact Integra LifeSciences or Medline’s Recall Department, or refer to the official documentation in the FDA’s recall database.
