Integra® INS8700Recalls & reported problems
Integra Lifesciences Corporation · Integra® External CSF Drainage System Replacement Bags · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780071013), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper Flow or Infusion1
- Use of Device Problem1
Patient problems
- Headache1
- Pneumocephalus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Use of Device Problem; Improper Flow or Infusion; Use of Device Problem; Improper Flow or Infusion
THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00191, 3013886523-2025-00192, 2648988-2025-00028. THIS ISSUE OCCURRED IN THE ICU & NEURO DEPARTMENTS OF THE FACILITY REGARDING THE FUNCTION OF THE DEVICES: 821730C (EDS3 DRAINAGE SYSTEM); INS8700 (INTEGRA EXTERNAL CSF DRAINAGE REPLACEMENT BAGS): DATE OF EVENT: BEGINNING JUNE 9TH 2025 (DURING SEVERAL WEEKS). FACILITY REPORTED: INCREASED FLOW RATE WHEN THE VALVE IS OPENED TO EMPTY THE CHAMBER. AIR RISING IN THE CATHETER, HYPER-DRAINAGE, SLOW EMPTYING, AIR APPEARING IN THE PATIENT'S VENTRICLE (VISIBLE ON CT SCAN), IMMEDIATE ACTION(S) TAKEN: CHANGE OF EQUIPMENT, DISCONTINUE USE. ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED AS FOLLOWS: HOW MANY TIMES HAS THIS MALFUNCTION BEEN OBSERVED? ANSWER: ABOUT FIFTY BAG MALFUNCTIONS AND AIR RISING DUE TO SLOW EMPTYING. ON WHAT DATES? ANSWER: FOR A YEAR OR MORE, BECAUSE AT THE BEGINNING THEY NOTICED VERY SLOW EMPTYING (SEVERAL MINUTES TO EMPTY A BAG SO SOME NURSES WENT TO SEE OTHER PATIENTS WHILE WAITING (BUT BE CAREFUL: RISK OF FORGETTING) OR OTHERS USE A SYRINGE TO SPEED UP EMPTYING IN ACCORDANCE WITH THE RULES OF ASEPSIS (BUT RISK OF AGGRAVATING HYPER-DRAINAGE, AND FORGETTING A
Patient problems: Headache; Pneumocephalus
MAUDE report 22620870 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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