Skip to content

N/A (REF 81120)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Steerable Diagnostic EP Catheter, 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 00885825009625), received between Feb 20, 2018 and Feb 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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

  • Defective Device1

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.

  • MalfunctionFeb 20, 2018Defective Device; Defective Device

    IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS BAD. THE COMPLAINANT IS UNAWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7283273 ↗

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.