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N/A (REF 2028BL)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Steerable Diagnostic EP Catheter , STANDARD, 8 electrodes, 2.5-5-2.5mm spacing, 7F · Class 2

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 00885825007959), received between Feb 26, 2018 and Feb 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult To Position” (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

  • Difficult To Position1

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.

  • MalfunctionFeb 26, 2018Difficult To Position; Difficult To Position

    IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER DID NOT WORK PROPERLY. THE ELECTROPHYSIOLOGY CATHETER DID NOT DEFLECT PROPERLY. 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 7296809 ↗

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.