EMPOWER™ 00884450491324Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450491324), received between Jul 2, 2025 and Jul 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE ACCOUNT ALLEGES THAT DURING AN THE EXTRACTION PROCEDURE AFTER A DUAL CHAMBER TRANSVENOUS ICD, THE LEADLESS PACEMAKER WAS NOT ABLE TO BE SNARED BY THE RETRIEVAL SYSTEM WITH EITHER THE SINGLE OR MULTI-LOOP SNARES, DUE TO SUSPECTED ENCAPSULATION OF THE DEVICE. THEREFORE, THE LEADLESS PACEMAKER (LCP) WAS PROGRAMMED OFF AND WAS ABANDONED. IT WAS NOTED THE PROCEDURE WAS PROLONGED BY AT LEAST AN HOUR WITH THE UNSUCCESSFUL EFFORTS TO RETRIEVE THE LCP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. MULTIPLE ATTEMPTS AT SNARING THE EMPOWER PACEMAKER WERE ATTEMPTED WITH BOTH THE SINGLE AND MULTI-LOOP SNARES. PROCEDURE WAS ABANDONED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22384427 ↗
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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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