SAFEGUARD™ 10884450246563Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450246563), received between Jul 26, 2023 and Aug 1, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Leak/Splash” (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
Device problems
- Leak/Splash2
- Material Puncture/Hole2
Patient problems
- Cardiac Arrest2
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
THE ACCOUNT ALLEGES THAT THERE HAS BEEN A LIFE-THREATENING EPISODE WITH ONE OF THEIR ITU PATIENTS INVOLVING A SAFEGUARD COMPRESSION DEVICE (24CM FEMORAL). THE DEVICE WAS DEFECTIVE AFTER APPLICATION, AND THE COMPRESSION EXERTED TO ACQUIRE HEMOSTASIS WAS INADEQUATE. IT LOOKS LIKE THE BALLOON WAS PUNCTURED SOMEHOW AND THE DEVICE LOST AIR QUICKLY. WHEN THE HOSPITAL STAFF REALIZED THE SITUATION FOUR HOURS LATER, THERE WAS FEMORAL BLEEDING DISCOVERED. THE PATIENT EXPERIENCED CARDIAC ARREST. A CODE WAS CALLED, AND CARDIOPULMONARY RESUSCITATION PROTOCOLS WERE EFFECTIVE.
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding
MAUDE report 17438621 ↗InjuryJul 26, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
THE ACCOUNT ALLEGES THAT THERE HAS BEEN A LIFE-THREATENING EPISODE WITH ONE OF THEIR ITU PATIENTS INVOLVING A SAFEGUARD COMPRESSION DEVICE (24CM FEMORAL). THE DEVICE WAS DEFECTIVE AFTER APPLICATION, AND THE COMPRESSION EXERTED TO ACQUIRE HEMOSTASIS WAS INADEQUATE. IT LOOKS LIKE THE BALLOON WAS PUNCTURED SOMEHOW AND THE DEVICE LOST AIR QUICKLY. WHEN THE HOSPITAL STAFF REALIZED THE SITUATION FOUR HOURS LATER, THERE WAS FEMORAL BLEEDING DISCOVERED. THE PATIENT EXPERIENCED CARDIAC ARREST. A CODE WAS CALLED, AND CARDIOPULMONARY RESUSCITATION PROTOCOLS WERE EFFECTIVE.
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding
MAUDE report 17399724 ↗
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- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR65 reports
- Flo-Thru Intraluminal Shunt® FT-12225Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 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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