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N/A (REF 81207)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Steerable Diagnostic EP Catheter Super Large, 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 00885825009830), received between Dec 15, 2020 and Dec 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

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.

  • MalfunctionDec 15, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THE DUADECA CATHETER HAD A SIGNIFICANT CURVE AND COULD NOT BE USED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11008532 ↗

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.