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EnSite™ Velocity ArrayLinkRecalls & reported problems

St. Jude Medical, Inc. · Module · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734210706), received between Jun 27, 2018 and Jun 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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

  • Device Displays Incorrect Message1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 27, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

    DURING THE PROCEDURE, A DATA MODULE ERROR WAS RECEIVED WHEN VALIDATING THE CATHETER. THE CATHETER WAS REPLACED BUT THE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7644502 ↗

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Sources and updates

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