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N/A (REF 7004D)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Steerable Diagnostic EP Catheter , STANDARD, 10 electrodes, 2-8-2mm spacing, 6F · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885825008727), received between Nov 20, 2018 and Apr 30, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 reports).

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

  • Positioning Failure3
  • Break2
  • Positioning Problem1

Patient problems

  • No Consequences Or Impact To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 30, 2019Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT THE STEERING WAS BROKEN ON THE EP CATHETER DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8567136 ↗
  • MalfunctionApr 30, 2019Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT THE STEERING WAS BROKEN ON THE EP CATHETER DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8567134 ↗
  • MalfunctionFeb 5, 2019Break; Positioning Problem; Break; Positioning Problem

    IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER DID NOT WORK; THE STEERING IS BROKEN. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8307914 ↗
  • MalfunctionNov 20, 2018Break; Positioning Failure; Break; Positioning Failure

    IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS BROKEN AND DOES NOT STEER. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8092392 ↗

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.