Worley™ Adv. LVI 00884450169797Recalls & reported problems
Merit Medical · Class 2
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 00884450169797), received between May 21, 2026 and May 21, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Low Blood Pressure/ Hypotension1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 21, 2026Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTS A RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY PLACED, THEN AN ATRIOVENTRICULAR NODE ABLATION WAS PERFORMED. LASTLY, CORONARY SINUS (CS) ACCESS WAS GAINED WITH THE WORLEY SYSTEM. WHILE SEARCHING FOR A VEIN TO IMPLANT THE LV LEAD, THE PATIENTS BLOOD PRESSURE DROPPED. AN EMERGENT ECHO WAS PERFORMED SHOWING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS INITIATED AND FLUID WAS PULLED OFF THE PERICARDIUM. THE PATIENT KEPT HAVING PULSELESS ELECTRICAL ACTIVITY (PEA) EVENTS AND PULMONARY RESUSCITATION WAS INITIATED. EVENTUALLY THE PATIENT PASSED AND TIME OF DEATH WAS CALLED. IN REVIEW OF THE FLOURO IMAGES, THE WIRE WAS IN THE CS OUTSIDE OF THE CARDIAC SHADOW. THIS WAS BELIEVED TO BE THE CAUSE OF THE EFFUSION. FOLLOW-UP MDT REP COMMUNICATION: "YES, THE WORLEY WAS THOUGHT TO BE THE CAUSE."
Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion
MAUDE report 25243523 ↗
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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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