GUARDIAN IPN914182Recalls & reported problems
Teleflex Incorporated · Guardian II NC Intro Torque · Class 2
Data updated Oct 16, 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 10841156101367), received between Feb 1, 2024 and Feb 1, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- Arrhythmia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 1, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT: ON (B)(6) 2024, DR. WAS FIXING A CX ARTERY WITH A GUARDIAN HEMOSTASIS VALVE. THERE WAS AN AIR LEAK INTO THE VESSEL AN AIR EMBOLUS WAS NOTED IN THE CIRCUMFLEX ARTEY AND PATIENT WENT INTO ARRYTHMIAS. PATIENT HAD CPR INITIATED AND SHE WAS INTUBATED, AND THE CASE WAS ABORTED TO STABILIZE PATIENT. PATIENT WENT TO THE ICU, STILL INTUBATED, BUT EXPECTED TO RECOVER. ADDITIONAL INFORMATION RECEIVED ON 08JAN2024: THE GUARDIAN APPARENTLY WAS LEAKING SOME BLOOD FROM THE PROXIMAL HUB THE ROTOLOCK WAS IN THE OPEN POSITION FOR THE DURATION OF THE CASE THE PATIENT HAD A MINIMAL BLOOD LEAK DURING THE CASE. ADDITIONAL INFORMATION RECEIVED ON 08JAN2024: PATIENT IS EXTUBATED AND DOING FINE, AS OF TODAY.
Patient problems: Arrhythmia
MAUDE report 18622604 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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