Guardian® II hemostasis valve 8211Recalls & reported problems
Vascular Solutions, Inc. · The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67mm) during diagnostic/interventional procedures. The torque device is provided as an aid for steering the guidewire within the vascular anatomy. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M20682110), received between Oct 21, 2016 and Oct 21, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2016Device Operates Differently Than Expected
PATIENT PRESENTED TO THE CARDIAC CATHETERIZATION LAB FOR A LEFT HEART CATHETERIZATION WITH CORONARY ANGIOGRAPHY ANGIOPLASTY, INTRACORONARY STENT PLACEMENT FOLLOWING A NON-STEMI MI ON (B)(6) 2016. DURING POST STENT ANGIOGRAM AIR EMBOLIZATION HAD OCCURRED WITH TIMI 0 FLOW IN THE LEFT CORONARY ARTERY. ANGIOGRAPHIC "AIR LOCK" WAS PRESENT. EPINEPHRINE WAS ADMINISTERED AND CPR INITIATED BUT ONLY LASTED 1 -1 ½ COMPRESSIONS WHEN THE PATIENT SPOKE. ANGIOGRAM AGAIN PERFORMED (AIRLOCK RESOLVED AND PATIENT HAD RESOLUTION OF FLOW TO TIMI - 3) PATIENT WAS TRANSFERRED TO ICU. PATIENT WAS MOVING EXTREMITIES ON COMMAND, AWAKE, NO COMPLAINT OF CHEST PAIN. THE PATIENT DID WELL AND WAS DISCHARGED HOME ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6046792 ↗
Other Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass devices
- Indeflator 1003327Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls722 reports
- Copilot 1003331Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass189 reports
- DLP® 11001GMedtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls0 reports
- RHV 23242Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass66 reports
- PhD™ 00884450746745Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- DLP® 14000Medtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746714Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- NAMIC 64038301Medline Industries, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
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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