Integra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error
Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Catheters because incorrect assembly may allow cerebrospinal fluid or blood to leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential leak of cerebrospinal fluid or blood from a medical device, which poses a risk of harm, but the source does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,218 units of the Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L. The recall is due to a potential assembly error where the o-ring in the bolt adapter may be located incorrectly.
This defect creates a risk that cerebrospinal fluid (CSF) or blood could leak from the bolt adapter. The affected devices are sterile transducer-tipped pressure monitoring catheters used by qualified neurosurgeons to measure intracranial pressure. The products were distributed nationwide in the United States and internationally to Argentina, Brazil, Bulgaria, Canada, Colombia, Costa Rica, France, Germany, Italy, Mexico, Panama, South Africa, Spain, Switzerland, the United Arab Emirates, and the United Kingdom.
Healthcare facilities should stop using the affected devices and contact Integra LifeSciences for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 1,218
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 305000291459
- 305000299228
- 305000300396
- 305000301413
- 305000312261
- 305000315716
- 30500X294240
- 30500X304371
- 30500X309674
- 30500X318076
- 3050RX285879
- 3050RY297365
- 305E00318970
- 305E0X320986
Distribution
Distributed nationwide across the United States.
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