HermeticRecalls & reported problems across all models
Integra Lifesciences Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 3 models of Hermetic by Integra Lifesciences Corporation in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2016 and Aug 6, 2026 — classified as 17 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Hermetic problems
Device problems
- Physical Resistance/Sticking13
- Break11
- Material Split, Cut or Torn8
- Difficult to Insert5
- Disconnection5
- Difficult to Remove4
- Material Fragmentation4
- Material Separation3
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Foreign Body In Patient11
- Insufficient Information8
- Device Embedded In Tissue or Plaque3
- No Known Impact Or Consequence To Patient3
- Cerebrospinal Fluid Leakage2
- Cerebral Ventriculomegaly1
- Implant Pain1
Hermetic models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hermetic™ INS5010Shunt, central nervous system and components59 reports
- Hermetic™ INS8330Shunt, central nervous system and components3 reports
- Hermetic™ INS4000Shunt, central nervous system and components1 report
Recent Hermetic adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Difficult to Remove; Physical Resistance/Sticking
MalfunctionApr 24, 2026Complete Blockage; Physical Resistance/Sticking
AN AUTHORIZED DISTRIBUTOR REPORTED THAT LUMBAR DRAIN ACCESS WAS SUCCESSFULLY INSERTED, YET UPON REMOVAL OF THE LUMBAR CATHETER STYLET, THERE WERE SOME DIFFICULTIES WHILE REMOVING THE GUIDEWIRE OR THE STYLET. WHEN MORE FORCE WAS APPLIED TO REMOVE THE STYLET, IT CAME OUT OF THE CATHETER, BUT IT WAS LOOSE AND THINNER, SO THEY REMOVED THE CATHETER AND USED A NEW ONE AND THE SAME PROBLEM HAPPENED. THEY TRIED FOR THE THIRD TIME, AND IT HAPPENED AGAIN; HOWEVER THEY KEPT THE THIRD CATHETER INSIDE AND DECIDED TO TRY TO DRAIN, BUT IT WASN'T DRAINING PROPERLY. THEY THEN DECIDED TO STOP AND REPORT THE INCIDENT. ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR: 1. END USER FACILITY? ANSWER: NEUROSURGERY CONSULTANT, (B)(6). 2. IS IT POSSIBLE TO HAVE AN ESTIMATION OF TIME INCREASE? IS IT LESS OR MORE THAN 30 MINUTES? ANSWER: YES, MORE THAN 30 MINUTES. 3. WERE THERE ANY ADDITIONAL CONSEQUENCES FOR THE PATIENT? ANSWER: NO. 4. COULD THE MEDICAL TEAM USE (NORMALLY) OR THEY HAVE TO INSERT ANOTHER ONE? ANSWER: THEY INSERTED TWO NEW CATHETERS, AND THEY COULDN'T DRAIN PROPERLY. 5. COULD YOU PLEASE LET US KNOW IF THE DEVICE OR THE DAMAGED PART IS AVAILABLE FOR INVESTIGATION? ANSWER: NOT REPORTED YET,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984998 ↗MalfunctionApr 24, 2026Disconnection
A FACILITY REPORTED THAT THE YELLOW CONNECTOR WAS NOT SEALED ON THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010), AND AS A CONSEQUENCE, THERE WAS LEAKAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24984370 ↗MalfunctionMar 31, 2026Physical Resistance/Sticking
A FACILITY REPORTED THAT DURING PLACEMENT OF A DSE (DRAINAGE SYSTEM EXTENSION) CATHETER UNDER STERILE CONDITIONS, THREE PUNCTURES WERE PERFORMED. AND THE EPIDURAL SPACE WAS IDENTIFIED AT THE L3-L4 LEVEL. CEREBROSPINAL FLUID (CSF) OUTFLOW UNDER PRESSURE WAS OBSERVED, CONSISTENT WITH THE PATIENT'S KNOWN SUBARACHNOID HEMORRHAGE (SAH). THE MANDREL-REINFORCED CATHETER WAS ADVANCED WITHOUT DIFFICULTY, AND THE INTRODUCER NEEDLE WAS REMOVED UNEVENTFULLY. UPON REMOVAL OF THE MANDREL, THE MANDREL FRACTURED, WITH THE BRAIDED WIRES UNRAVELING AND TWO WIRES SNAPPING, RESULTING IN DAMAGE TO THE DISTAL PORTION OF THE CATHETER. THE MANDREL WAS FULLY REMOVED; THE DISTAL 10-12 CM APPEARED INTACT ON INSPECTION. AS A PRECAUTION, THE PHYSICIAN CUT THE CATHETER AT THE LEVEL OF THE FISSURE/BREAK BEFORE CONNECTING THE CATHETER TO THE CSF DRAINAGE COLLECTION SYSTEM USING THE PROVIDED CONNECTOR. THE CATHETER WAS WET BUT NOT FULLY PRIMED WITH FLUID PRIOR TO USE. THE MANDREL WAS NOT WRAPPED AROUND THE OPERATOR'S FINGERS OR HAND DURING WITHDRAWAL. THE INCIDENT RESULTED IN A SIGNIFICANT INCREASE IN PROCEDURE TIME OF APPROXIMATELY 1 HOUR. HOWEVER, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742094 ↗InjuryMar 7, 2026Disconnection
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 2648988-2026-00006: MEDWATCH "MW5182169" WAS RECEIVED WITH THE FOLLOWING INFORMATION: "INTEGRA HERMETIC LUMBAR CATH. CLOSED TIP INS5010 AND INTEGRA DRAINAGE SYSTEM INS8401 LUMBAR DRAIN INSERTED AND DRESSING PLACED OVER SITE. CONNECTION BETWEEN LUMBAR CATHETER AND DRAINAGE SYSTEM WAS NOT WITHIN THE DRESSING. THE TUBING OF THE LUMBAR CATHETER BECAME DISCONNECTED FROM THE CONNECTION POINT. TUBING PULLED FREE OF CONNECTION POINT MALE ADAPTER THAT THEN CONNECTS TO DRAINAGE SYSTEM TUBING. UNCLEAR HOW IT BECAME DISCONNECTED AS IT WAS REPORTED TO BE FUNCTIONAL WITH LAST ASSESSMENT. UPON NEXT ASSESSMENT DRAINAGE SYSTEM FOUND TO HAVE NO NEW OUTPUT, AIR FOUND IN TUBING, AND TUBING DISCONNECTED AT CONNECTION POINT MALE ADAPTER. PATIENT DEVELOPED PNEUMOCEPHALUS REQUIRING SURGICAL INTERVENTION WHICH WAS COMPLETED A PLANNED PROCEDURE WHICH WAS MOVED UP DUE TO PNEUMOCEPHALUS. CEREBROSPINAL FLUID LEAK DUE TO HEAD TRAUMA, HISTORY OF CRANIOTOMY. PT-4587, DEVICE-2900. REFERENCE REPORTS - MW5182170. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED AS FOLLOWS: 1. PLEASE PROVIDE THE REPORTING FACILITY NAME. (B)(6). 2. PLEASE PROVIDE THE COMPLETE ADDRESS
Patient problems: Cerebrospinal Fluid Leakage; Pneumocephalus
MAUDE report 24540402 ↗MalfunctionDec 29, 2025Disconnection; Disconnection
A FACILITY REPORTED THAT A PATIENT WITH LUMBAR DRAINAGE AFTER AN ANTERIOR COMMUNICATING ARTERY ANEURYSM EXPERIENCED ACCIDENTAL DISCONNECTION OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) FROM THE COLLECTION SYSTEM, LEADING TO REMOVAL OF THE CATHETER DUE TO INFECTION RISK. IMAGING SHOWED VENTRICULAR ENLARGEMENT, AND A NEW LUMBAR CATHETER WAS INSERTED. RISKS INCLUDED EXCESSIVE CSF LOSS IF UNNOTICED AND INFECTION. THE CONNECTION BETWEEN THE CATHETER AND THE COLLECTION SYSTEM APPEARED INSUFFICIENTLY SECURED. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED AS FOLLOWS: "THE COLLECTION SYSTEM USED IS THE VENTREX COMPLETE EVD SYSTEM FROM NEUROMEDEX (REF: (B)(4)). HOWEVER, THE MALFUNCTION DOES NOT OCCUR AT THE JUNCTION BETWEEN THE CATHETER AND THE COLLECTION SYSTEM. THE MALFUNCTION IS UPSTREAM, ENTIRELY ON THE INTEGRA SYSTEM. IN PRACTICE, AFTER INSERTING THE DRAINAGE CATHETER, WE INSERT A CONNECTOR INTO IT THAT WILL ALLOW IT TO CONNECT THE FLEXIBLE CATHETER TO THE NEUROMEDEX SYSTEM. THE ACCIDENTAL DISCONNECTION OCCURRED THERE IN OUR CASE."
Patient problems: Cerebral Ventriculomegaly
MAUDE report 23917252 ↗MalfunctionOct 24, 2025Complete Blockage; Complete Blockage
MalfunctionOct 9, 2025Difficult to Insert; Difficult to Insert
AN AUTHORIZED DISTRIBUTOR REPORTED THAT IT WAS DIFFICULT TO INSERT THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) THROUGH THE TUOHY NEEDLE, AS IF THE CATHETER HAD LOST ITS ELASTICITY. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: 1. FOR HOW LONG DID THE DYSFUNCTION LEAD TO INCREASE SURGERY TIME? ANSWER: IT TOOK MORE THAN AN HOUR TO SECURE THE LUMBER DRAIN (STERILE TECHNIQUE BEFORE SURGERY). 2. HOW DID THE MEDICAL TEAM FINISH THE PROCEDURE (USING THIS UNIT OR ANOTHER ONE¿)? ANSWER: DRAIN INSERTED AS PLANNED PREOP. WITH DIFFICULTIES, DIFFICULT TO PASS THE SILICON DRAIN INTO SPINAL NEEDLE CATHETER (RESISTANCE) AND, AT THE END, SO DIFFICULT TO REMOVE THE SPINAL NEEDLE WHILE THE CATHETER IS IN THE SPINE, RISKING PUNCTURING THE SILICON TUBE OR CAUSING ITS FRACTURE. 3. HOW IS THE PATIENT NOW? ANSWER: HE IS FINE, HOWEVER, THE TEAM DIDN'T LIKE THE LUMBAR DRAIN EXPERIENCE, AND I FEEL IT IS SO RISKY, ESPECIALLY IF THE DRAIN FRACTURE AND PIECE LEFT INTRASPINAL. 4. END USER HEALTHCARE FACILITY? ANSWER: PRINCE SULTAN MILITARY MEDICAL CITY IN (B)(6) (SAUDI ARABIA).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23259913 ↗MalfunctionOct 9, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE TIP OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) WAS CUT BY THE TUOHY NEEDLE DURING INSERTION, AND THAT THE ISSUE OCCURRED WITH 2 DIFFERENT PATIENTS. THEY TRIED TO RETRIEVE THE OTHER END (AS IT GOT STUCK INSIDE) AND HAD TO DO ANOTHER TRIAL OF INSERTION. THE PATIENT WAS REPORTED AS "SYMPTOMATIC", BUT THE NATURE OF THE SYMPTOMS HAVE NOT BEEN REPORTED. THE DYSFUNCTION LED TO INCREASED SURGERY TIME OF AN HOUR. END USER HEALTHCARE FACILITY: (B)(6).
Patient problems: Insufficient Information
MAUDE report 23259900 ↗MalfunctionSep 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
A FACILITY REPORTED THE FOLLOWING: "THE DOCTOR PERFORMED A DSE CATHETER PLACEMENT ON PATIENT (FEMALE). AFTER EASILY IDENTIFYING THE SUBDURAL SPACE, THE DOCTOR INSERTED THE GUIDEWIRE (AFTER ADEQUATELY LUBRICATING IT WITH SALINE TO ALLOW FOR BETTER SLIDING). THE PROGRESSION WAS SMOOTH, SO THE DOCTOR REMOVED THE METAL NEEDLE AND BEGAN TO EXTRACT THE GUIDEWIRE WITH ONE HAND, HOLDING THE CATHETER STEADY WITH THE OTHER. THE DOCTOR FELT RESISTANCE AND NOTICED A CURLING OF THE CATHETER AT THE DISTAL END, A SENSATION NOT DIFFERENT FROM PREVIOUS PLACEMENTS. UPON REMOVAL OF THE WHOLE CATHETER, A BREAKAGE OF THE CATHETER'S MANDREL WAS EVIDENT. THE MANDREL APPEARED TO BE MADE OF SEVERAL INTERTWINED WIRES, ONE OF THEM APPEARED TO BE UNTANGLED AND CUT. THE MANDREL, HOWEVER, WAS INTACT AT THE END. THE DOCTOR DID NOT NOTICE ANY LESIONS OR ABNORMAL LEAKAGE OF CEREBROSPINAL FLUID FROM THE CATHETER." ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: - COULD YOU PLEASE CLARIFY THIS STATEMENT "UPON REMOVAL OF THE WHOLE CATHETER, A BREAKAGE OF THE CATHETER'S MANDREL WAS EVIDENT." WAS THE CATHETER REMOVED COMPLETELY, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE? OR WAS THE CATHETER'S MANDREL (GUIDEWIRE)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22983897 ↗MalfunctionJul 18, 2025Difficult to Advance; Difficult to Advance
A FACILITY REPORTED THAT DURING TEVAR PROCEDURE, THE GUIDEWIRE PERFORATED THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS5010) ON INSERTION. THE DOCTOR FELT RESISTANCE ON INSERTION OF LUMBAR CATHETER; IT WAS A CHALLENGING INSERTION WITH DIFFICULTY FEEDING THE CATHETER WITH HIGH RESISTANCE. DUE TO THE AMOUNT OF RESISTANCE ENCOUNTERED, THE DOCTOR WITHDREW THE CATHETER, AND IT WAS THEN NOTED THAT THE GUIDE WIRE HAD PERFORATED THE TIP OF THE CATHETER. THE DOCTOR REINSERTED ANOTHER LUMBAR CATHETER WITHOUT ISSUE. THE SURGERY WAS DELAYED FOR 60 MINUTES DUE TO THE PROBLEM ENCOUNTERED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22549391 ↗MalfunctionJun 20, 2025Disconnection; Disconnection
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 2648988-2025-00024. A FACILITY REPORTED THAT A PATIENT WAS TREATED FOR EVACUATION OF A LEFT TEMPORAL INTRAPARENCHYMAL HEMATOMA FOLLOWING A MECHANICAL FALL WITH HEAD TRAUMA. ON (B)(6), THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR EXTERNAL LUMBAR CEREBROSPINAL FLUID (ESF) DRAIN INSERTION EARLY IN THE NIGHT. UPON RETURNING TO THE ROOM, THE DRAIN TUBING BECAME MISMATCHED, RESULTING IN A POOL OF CEREBROSPINAL FLUID (CSF) IN THE BED (CONNECTED TO THE COMPLETE VENTRICULAR DRAINAGE SYSTEM (EVD REF: (B)(4), LOT: 412147, CORMEDICA => ANOTHER BRAND). THE DRAIN WAS CLAMPED AND RE-FITTED IN THE ROOM WITHOUT CHANGING THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302436 ↗InjuryJun 10, 2025Entrapment of Device; Entrapment of Device
MalfunctionJun 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
A FACILITY REPORTED THAT DURING PLACEMENT OF THE HERMETIC LUMBAR CATHETER, CLOSED TIP (INS500), THE OPERATOR WAS UNABLE TO REMOVE THE RIGID GUIDEWIRE, WHICH GRADUALLY FRAYED UNTIL IT BROKE, RESULTING IN FAILURE OF THE EXTERNAL LUMBAR SHUNT DEVICE. A NEW PUNCTURE WAS REQUIRED, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE LASTED A TOTAL OF ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: HOW IS THE PATIENT DOING NOW? ANSWER: THE INCIDENT HAS NOT YET CAUSED ANY HARM TO THE PATIENT, AND THEIR CURRENT CONDITION IS UNRELATED TO THE INCIDENT OBSERVED. I AM UNABLE TO PROVIDE YOU WITH FURTHER INFORMATION ON THE PATIENT'S HEALTH. PROVEN CONSEQUENCES: ANSWER: DOUBLE SPINAL PUNCTURE AND PROLONGED MANIPULATION IN A PATIENT WITH INTRACRANIAL HYPERTENSION REQUIRING A BOLUS OF BARBITURATE + 20% NACL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22180236 ↗MalfunctionMay 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
A FACILITY REPORTED THAT A HERMETIC LUMBAR CATHETER (INS5010) WAS POSITIONING TO THE PATIENT, AND AFTER HAVING EASILY IDENTIFIED THE SUBDURAL SPACE, THE GUIDE WIRE WAS INSERTED (AFTER HAVING ADEQUATELY LUBRICATED IT WITH SALINE SOLUTION TO ALLOW FOR BETTER SLIDING). THE PROGRESSION WAS FLUID, THE METAL NEEDLE WAS REMOVED, AND EXTRACTION BEGAN WITH ONE HAND WHILE HOLDING THE CATHETER FIRMLY WITH THE OTHER HAND. THERE WAS RESISTANCE WITH THE CATHETER CURLING IN THE DISTAL PART. UPON REMOVAL OF THE ENTIRE CATHETER, A BREAKAGE OF THE CATHETER SPINDLE ITSELF WAS EVIDENT. THE SPINDLE APPEARS TO BE MADE OF SEVERAL INTERTWINED WIRES OF WHICH ONE APEX SEEMED TO BE UNTWISTED AND CUT. THE SPINDLE WAS; HOWEVER, INTACT AND IN THE FINAL PART. NO LESIONS OR ABNORMAL LEAKS OF LIQUOR FROM THE CATHETER ITSELF WAS NOTICED. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: ¿ NO PATIENT INJURED. ¿ INCREASE OF SURGERY TIME :1 HOUR. ¿ PRODUCT IS LOST, SO THEY DO NOT KNOW LOT/DEADLINE AND THEY WILL NOT RETURN THE CATHETER. ¿ THE PATIENT HAD NO LESIONS DUE TO THE PROBLEM AND THE SURGERY WAS NOT DELAYED. THEY HAD TO REPOSITION A NEW CATHETER THOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061224 ↗
Other Integra Lifesciences Corporation products
All Integra Lifesciences Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page