Hermetic™ II NL8508330Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780072393), received between Aug 29, 2024 and Jun 17, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Break; Break

  MEDWATCH #MW5170290 WAS RECEIVED AND REPORT AS FOLLOWS: "DURING PLACEMENT OF LUMBAR DRAIN CATHETER, THE CATHETER BROKE INSIDE THE PATIENT LOWER BACK. THE ATTENDING SURGEON VERIFIED AND CONFIRMED THAT THE CATHETER WAS RETAINED. ABOUT 4 INCHES OF THE CATHETER WAS RETAINED."

  Patient problems: Foreign Body In Patient

  MAUDE report 22235209 ↗
• MalfunctionMay 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008782 ↗
• InjuryNov 27, 2024Material Perforation; Material Perforation

  MEDSUN UF/IMPORTER REPORT :(B)(4). WAS RECEIVED WITH THE FOLLOWING INFORMATION: "THE NEUROSCIENCES UNITS (NICU, SP 6-3) ARE CURRENTLY RECEIVING A SUBSTITUTE LUMBAR DRAIN PRODUCT (NL8508330) THAT CONTAINS A RIGID METAL CONNECTOR PIECE INSTEAD OF A FLEXIBLE PLASTIC CONNECTOR FOUND IN THE STANDARD LD (LUMBAR DRAIN) KIT. THIS ITEM CONNECTS THE CATHETER TO THE DRAINAGE SYSTEM AND IS SUSPECTED TO BE CAUSING PUNCTURES IN THE LUMBAR DRAINS, CONTRIBUTING TO OVER DRAINAGE OF CSF. THESE SAFETY EVENTS HAVE OCCURRED TWICE IN THE RECENT MONTH AND NO PATIENT HARM OCCURRED. RN WENT TO SEE HER PATIENT IN ROOM 7120, AT 12AM TO T&P AND BATH PATIENT. AT THAT TIME PATIENT WAS INTACT AND LUMBAR DRAIN WAS INTACT WITH NO DRAINAGE NOTED. [REDACTED NAME] WENT BACK IN AT 1AM TO ASSESS THE PATIENT, AND AGAIN PATIENT REMAINED INTACT AND NO EVIDENCE OF DRAINAGE FROM LUMBAR DRAIN. AT 1:40AM SHE RETURNED TO ASSESS HER PATIENT WHICH THEN SHE NOTED PATIENT BONE FLAP WAS SUNKEN IN, WHICH WAS DIFFERENT THAN HER 1AM EXAM...BONE FLAP AT THAT TIME APPEARED NORMAL, ROUNDED. [REDACTED NAME] QUESTIONED WHY THE SUDDEN CHANGE IN BONE FLAP APPEARANCE AND REALIZED THERE WAS A SIGNIFICANT AMOUNT OF CLEAR DRAINAGE NOTED ON THE P

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 20803048 ↗
• MalfunctionOct 18, 2024Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS RELATED TO MFG REPORT NUMBER: 2648988-2024-00032 FOR 2ND PATIENT THAT EXPERIENCED THE ISSUE: A FACILITY REPORTED THAT THE HERMETIC LUMBAR CATHETER (NL8508330) CONTAINS A RIGID METAL CONNECTOR PIECE INSTEAD OF A FLEXIBLE PLASTIC CONNECTOR FOUND IN THE STANDARD LUMBAR DRAIN KIT. THE ITEM CONNECTS THE CATHETER TO THE DRAINAGE SYSTEM AND IS SUSPECTED TO BE CAUSING PUNCTURES IN THE LUMBAR DRAINS, CONTRIBUTING TO OVER DRAINAGE OF CEREBROSPINAL FLUID (CSF). AFTER THE INCIDENT, THE PUNCTURE WAS REPAIRED AND A SEPARATE CONNECTOR WAS USED FROM ANOTHER LUMBAR DRAIN KIT. PATIENT EXPERIENCED NO SYMPTOMS FROM THE OVERDRAINAGE, AND THE FOLLOW UP CT SCANS WERE NOT CHANGED. LUMBAR DRAIN WAS KEPT CLAMPED. NO PATIENT HARM OCCURRED. MEDSUN REPORT#: (B)(4) RECEIVED WITH THE FOLLOWING INFORMATION: "THE NEUROSCIENCES UNITS (NICU, SP 6-3) ARE CURRENTLY RECEIVING A SUBSTITUTE LUMBAR DRAIN PRODUCT: (NL8508330) THAT CONTAINS A RIGID METAL CONNECTOR PIECE INSTEAD OF A FLEXIBLE PLASTIC CONNECTOR FOUND IN THE STANDARD LD KIT. THIS ITEM CONNECTS THE CATHETER TO THE DRAINAGE SYSTEM AND IS SUSPECTED TO BE CAUSING PUNCTURES IN THE LUMBAR DRAINS, CONTRIBUTING TO OVER DRAINAGE OF CSF. THESE SAFETY EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487216 ↗
• MalfunctionAug 29, 2024Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 20103826 ↗