Prelude IDeal™ 10884450317133Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Prelude IDeal (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450317133), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT A PATIENT DEATH OCCURRED AFTER THE PLACEMENT OF AN IDEAL SHEATH AT (B)(6) HOSPITAL, (B)(6). THE PATIENT WAS TO RECEIVE PERCUTANEOUS CARDIOPULMONARY SUPPORT [PCPS] DUE TO A FATAL CONDITION, SUSPECTED TO BE CAUSED BY COVID-19. THE SHEATH WAS PLACED TO INFUSE ARTERIAL BLOOD INTO THE PATIENT'S LOWER EXTREMITIES TO PREVENT LOWER-LIMB ISCHEMIA. ON (B)(6) 2020, THE IDEAL SHEATH ACCESS WAS ATTEMPTED IN AN ANTEGRADE FASHION VIA THE RIGHT FEMORAL ARTERY. THE PATIENT DEVELOPED A HEMATOMA DURING ACCESS ATTEMPT. MANUAL COMPRESSION WAS APPLIED AT THE ACCESS SITE TO CONTROL THE HEMATOMA WITH THE ACCESS SHEATH STILL IN PLACE. BLOOD WAS ALSO NOTED TO BE LEAKING FROM THE BASE OF THE SHEATH HUB DUE TO A CRACK THAT WAS IDENTIFIED AT THE STRAIN RELIEF PORTION OF THE SHEATH. AT AN UNKNOWN TIME AFTER THIS EVENT, THE PATIENT EXPIRED. CAUSE OF PATIENT DEATH HAS NOT BEEN CONFIRMED. THE COMPLAINT SAMPLE WILL NOT BE RETURNING BECAUSE OF THE SUSPECTED PATIENT INFECTION. (B)(4) IS TRYING TO TRACK DOWN THE PHYSICIAN FOR ADDITIONAL INFORMATION. A GOOD FAITH EFFORT OF 3 OR MORE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THIS ACCOUNT HAS BEEN SUCCESSFULLY COMPLETED
Patient problems: Hematoma
MAUDE report 11135947 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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