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N/A (REF D7-T20-282-RT)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Diagnostic EP Catheter Halo, 7F · Class 2

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 00885825001445), received between Oct 19, 2016 and Oct 19, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Knotted” (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

  • Knotted1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryOct 19, 2016Knotted

    IT WAS REPORTED THAT THE DEVICE BECAME KNOTTED WHILE IN THE PATIENT AND WAS UNTANGLED BY PHYSICIAN WITHOUT INCIDENT. TWO ADDITIONAL DUO CATHETERS WERE USED TO UNTIE THE DEVICE. THERE WAS NO PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6042582 ↗

Other CATHETER, RECORDING, ELECTRODE, REPROCESSED devices

All CATHETER, RECORDING, ELECTRODE, REPROCESSED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.