MBA™ 00884450024430Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 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 00884450024430), received between Jan 27, 2022 and Jan 27, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Air Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE WITHIN THE PATIENT'S BASILAR ARTERY, THE POSTERIOR THUMBWHEEL OF THE HEMODEVICE/TUOHY DETACHED DURING A MANUAL CONTRAST INJECTION. THE PHYSICIAN THEN REMOVED ALL INTERVENTIONAL EQUIPMENT FROM THE PATIENT AND REPLACE THE TUOHY DEVICE. POST PROCEDURE 4 HOURS LATER, A SMALL AIR BUBBLE WAS IDENTIFIED DURING CT SCAN WITHIN THE PATIENT'S DISTAL BASILAR ARTERY. THE NEXT DAY, (B)(6) 2021, THE PATIENT HAD EXPIRED. PHYSICIAN STATES THAT THE ACTUAL CAUSE OF DEATH IS UNKNOWN. PATIENT WAS UNCONSCIOUS AND INTUBATED BOTH PRE AND POST PROCEDURE.
Patient problems: Air Embolism
MAUDE report 13370239 ↗
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- RHV 23242Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass66 reports
- DLP® 14000Medtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746745Merit Medical Systems, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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