Schiller ECG wire set 2.410308Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613365000344), received between Oct 6, 2020 and Oct 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K012226, K221056); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 6, 2020Display or Visual Feedback Problem

  FROM STAFF: MERGE LEADS THAT ARE USED TO MONITOR ELECTROCARDIOGRAM FOR PROCEDURE WERE PLACED ON PATIENT (PT). PT ARRIVED TO THE INTERVENTIONAL LAB ROOM IN THE MORNING. THERE WERE NO ARRHYTHMIAS OR ARTIFACT NOTED AT THIS TIME PRIOR TO CASE START. ONCE TIME OUT WAS COMPLETED, AND LIDOCAINE WAS TRANSDERMALLY GIVEN IN THE RIGHT RADIAL TERRITORY THE RHYTHM SUDDENLY CHANGED TO WHAT APPEARED TO BE MONOMORPHIC VENTRICULAR TACHYCARDIA (THERE WAS NO INDICATION THAT IT WAS ARTIFACT DUE TO NO DELAY PRIOR TO CHANGE OF RHYTHM AND THE RHYTHM REMAINED IN THIS MONOMORPHIC STATE). DOCTOR WAS NOTIFIED AND THERE HAD BEEN APPROXIMATELY 5-6 SCREENS OF THIS VENTRICULAR TACHYCARDIA APPEARING RHYTHM. DOCTOR INITIATED CPR THEN REGISTERED TECHNOLOGIST OF RADIOGRAPHY IN ROOM TOOK OVER CPR. NURSE (RN) APPLIED DEFIB PADS WHILE ANOTHER RN TURNED ON DEFIB EQUIP TO PREPARE FOR SHOCK IF NEEDED. IT WAS NOTED PT WAS AWAKE BUT PT HAD RECEIVED SOME SEDATION MEDICATIONS. THE RHYTHM CONTINUED AND TO PREVENT PT FROM PASSING OUT IF THE RHYTHM WAS TRUE PT WAS PLACED ON DEFIB EQUIPMENT. AN 'ALL AVAILABLE HELP WAS CALLED' AND STAFF WERE NOTIFIED THAT A POTENTIAL CODE COULD BE OCCURRING. PRIOR TO CHARGING THE DEFIB THE ROOM CO

  Patient problems: Discomfort

  MAUDE report 10634651 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012226, K221056. One submission often covers many models, so check the product and lot details in each record.

• Z-2672-2025 · Aug 8, 2025 · Open, Classified
  Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006