SafeBreak - VascularRecalls & reported problems
Lineus Medical · SafeBreak Vascular is a Force-Activated Separation Device. It is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump. · Class 2
Data updated Oct 18, 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 10860635000311), received between Dec 16, 2024 and Dec 16, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Elevated Ketones/ Diabetic Ketoacidosis1
- Hyperglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
PROBLEM: LEAKS FROM THE END OF THE SAFEBREAK DEVICE & THE IV TUBING EVENT: (SPECIFIC DATE NOT PROVIDED). A NURSE REPORTED THAT WHILE MANAGING A PATIENT REQUIRING AN INSULIN INFUSION (INSULIN GTT) VIA GLUCOMMANDER, A LEAKING INTRAVENOUS (IV) CONNECTION WAS OBSERVED. UPON ENTERING THE PATIENT'S ROOM TO COSIGN A NEW BAG OF INSULIN, SHE NOTICED THE PATIENT HAD A PILLOW UNDER THEIR ARM, WHICH WAS SOAKED. THE INSULIN INFUSION WAS RUNNING THROUGH AN IV IN THE SAME ARM. THE ATTENDING NURSE REPORTED ONGOING LEAKAGE FROM THE IV SETUP, WHICH INCLUDED A SAFEBREAK DEVICE. UPON ASSESSING THE IV, SHE CONFIRMED THAT THE LEAKAGE ORIGINATED FROM THE END OF THE SAFEBREAK. AS A RESULT OF THIS LEAKAGE, THE GLUCOMMANDER SYSTEM DETECTED RISING BLOOD GLUCOSE LEVELS AND AUTOMATICALLY INCREASED THE INSULIN INFUSION RATE TO COMPENSATE, EVENTUALLY REACHING A HIGH DOSE. AFTER DISCONNECTING THE SAFEBREAK, THE INSULIN INFUSION RATE DECREASED, AND THE PATIENT'S GLUCOSE LEVELS STABILIZED.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 20941489 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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