EnSite™ VelocityRecalls & reported problems
St. Jude Medical, Inc. · RecordConnect · Class 2
Data updated Oct 13, 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 05414734210195), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Signal Artifact/Noise” (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.
Most reported problems
Device problems
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2021Signal Artifact/Noise; Signal Artifact/Noise
DURING THE TYPICAL CTI FLUTTER PROCEDURE, THE GE RECORDING CONNECT WAS PROMPTING NOISE. ANOTHER RECORDCONNECT WAS BROUGHT TO THE CASE FROM ANOTHER FACILITY AND THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. HOWEVER, A PROCEDURE DELAY OCCURRED DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12567667 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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