{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194454", "product_res_number": "Z-1395-2022", "event_date_initiated": "2022-06-22", "event_date_posted": "2022-07-22", "recall_status": "Open, Classified", "res_event_number": "90457", "product_code": "GWM", "k_numbers": [ "K210993" ], "product_description": "CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.", "code_info": "UDI-DI- 10381780533778; All serial numbers.", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "1100 Campus Rd", "city": "Princeton", "state": "NJ", "postal_code": "08540-6650", "additional_info_contact": "Lacey Gigante \n609-212-9004", "reason_for_recall": "Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message \"sensor or extension cable failure!\" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.", "root_cause_description": "Device Design", "action": "A recall notification titled 1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION, dated June 22, 2022, was sent by mail. This communicated troubleshooting techniques if an out-of-range reading is encountered when utilizing the Codman CereLink System, while Integra finalized a root cause investigation. \n\nA second notification, dated August 23, 2022, for this recall states that Integra is now conducting a removal of Codman CereLink ICP Monitors. Customers are asked to discontinue use of affected devices as soon as possible and remove the devices from service. \n\nIf an affected device is being used on a patient, continued use should only be determined by an individual risk-benefit analysis by the responsible attending clinician. If the recalled device continues to be used on a patient, the patient needs to be carefully monitored and ensure cable management. If a progressive decline in ICP readings is observed, use another monitoring system for continued patient case as soon as possible. Once patient care is complete, discontinue use of the monitor and remove it from service. \n\nAs CereLink ICP Monitors are removed from use, a sales representative will facilitate the return of the affected monitor. Complete the Acknowledgement Form and return it to your Account Manager or email it to FCA3@integralife.com or Fax the form to 1-609-750-4220. Keep a copy of the recall notification for your records. \n\nAny questions, contact your Integra Account Manager, Clinical Specialist, or Technical Support at technical.support@integralife.com or by phone at 888-772-7378.", "product_quantity": "1,210 units", "distribution_pattern": "Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.", "openfda": { "k_number": [ "K822636", "K896834", "K930221", "K862820", "K914735", "K120252", "K822864", "K121573", "K252241", "K113088", "K173192", "K974088", "K071505", "K982702", "K980380", "K882552", "K200630", "K893395", "K050702", "K022638", "K112017", "K945585", "K171666", "K863479", "K802149", "K962928", "K991222", "K131184", "K813440", "K062584", "K101133", "K943987", "K940648", "K210993", "K102875", "K772063", "K152670", "K802138", "K983799", "K802100", "K183406", "K153347", "K890468", "K840003", "K200456", "K040235", "K853770", "K172209", "K883518", "K161010", "K883115", "K801755", "K013705", "K051599", "K862012", "K010422", "K002392", "K141869", "K003905", "K201989", "K060554", "K232890", "K992591", "K853864", "K883881", "K912139", "K882286", "K003759", "K240821", "K840999", "K250285", "K032337", "K121159", "K844566", "K050720", "K072379", "K022553", "K182073", "K130529", "K854657", "K880154", "K020285", "K083378", "K914479", "K031086", "K981846", "K020780", "K042728", "K133754", "K790920", "K071984", "K802137", "K061640", "K013930", "K053244", "K103206", "K020558", "K162108", "K884823", "K931609", "K041838", "K002765", "K102077", "K201118", "K881183" ], "registration_number": [ "3024673", "3008114965", "3027605168", "9617601", "3044156918", "1526863", "3003733874", "9611274", "9612501", "3018094310", "1721983", "3006240422", "2030624", "3004920696", "3008791915", "3017180827", "3010611950", "3012266672", "3009865268", "3007156625", "8010468", "3006697299", "3014334038", "3042902796", "3007603826", "3012507533", "2916714", "3006946348", "3002108226", "3011689956", "3001587388", "3013944123", "1836324", "3006942548", "1220477", "3013886523", "2023988", "3023074935", "3009171251", "3023540124", "3014255018", "3015151147", "2953359", "3004114361", "9616567", "3023852420", "3003730855", "3007029079", "2024024", "3003418325", "2032112", "3002808022", "3043513133", "2011171", "3028006458", "3002807315", "3004070722", "3005067367", "3010763671", "3008102042", "3010948104", "3013557562", "3015531529", "3003851947", "2183744", "2029275", "3017636737", "3004593495" ], "fei_number": [ "3024673", "3008114965", "3044156918", "1526863", "3002808043", "3003733874", "3002534070", "3002806577", "3002998595", "3546", "3018094310", "3002924544", "3004920696", "3008791915", "3017180827", "3010611950", "3012266672", "3009865268", "3006697299", "1000064530", "3014334038", "3042902796", "3007603826", "3012507533", "2916714", "3006946348", "3003076831", "3002108226", "3001587388", "3011689956", "3003495548", "3013944123", "1220477", "3013886523", "2023988", "1625382", "1000306431", "3006759904", "3017636737", "3023074935", "3002963732", "3023540124", "3014255018", "3015151147", "3004114361", "3023852420", "3003730855", "3007029079", "2024024", "3003418325", "3043513133", "3002808022", "2011171", "3008133910", "3028006458", "3002807315", "3004070722", "3010763671", "3000206435", "3010948104", "3013557562", "3015531529", "3003851947", "2183744", "3006942548", "3000215205", "3004593495" ], "device_name": "Device, Monitoring, Intracranial Pressure", "medical_specialty_description": "Neurology", "regulation_number": "882.1620", "device_class": "2" } } ] }