Assert-IQ™ DM5100Recalls & reported problems
St. Jude Medical, Inc. · 4 Insertable Cardiac Monitor · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067055095), received between Jul 22, 2026 and Aug 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Data 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Data Problem1
- Failure to Interrogate1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506074 ↗MalfunctionJul 22, 2026Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25900522 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.