Tuohy 1150-4M200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14048223022648), received between Jan 7, 2020 and Jan 8, 2020 — classified as 2 deaths.

The most frequently reported specific device problem is “Off-Label Use” (2 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJan 8, 2020Off-Label Use; Off-Label Use

  THE FOLLOWING REPORT OF AN ADVERSE EVENT WAS PROVIDED TO PAJUNK MEDICAL SYSTEMS ON JANUARY 3, 2020: AN ADVERSE EVENT REPORT WAS RECEIVED, IN WHICH YOUR DEVICE WAS INVOLVED. EVENT DESCRIPTION: DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PLEURAL EFFUSION, CARDIAC ARREST AND SUBSEQUENT DEATH OCCURRED. WHILE ATTEMPTING EPICARDIAL ACCESS, A PLEURAL EFFUSION WAS CONFIRMED ON ICE AT THE RV APEX, SUGGESTIVE PERFORATION FROM THE PAJUNK NEEDLE. EPICARDIAL ACCESS WAS CONFIRMED WITH DYE VISUALIZED LAYERING AROUND THE PERICARDIAL SPACE. A WIRE WAS THEN ADVANCED AND OBSERVED TO CURL IN THE EPICARDIAL SPACE WITHOUT ADVANCING BEYOND THE CARDIAC SILHOUETTE. AN AGILIS SHEATH WAS THEN ADVANCED OVER THE WIRE INTO THE PERICARDIAL SPACE. A SECOND WIRE WAS ADVANCED INTO THE EPICARDIUM. THE AGILIS WAS REMOVED AND ADVANCED OVER ONE OF THE WIRES. THE WIRE AND DILATOR WERE FROM THE AGILIS AND THE REMAINING WIRE WAS SECURED TO THE DRAPE. APPROXIMATELY 290 CC OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. THE EFFUSION DID NOT REACCUMULATE AND WAS CLOSELY MONITORED DURING THE PROCEDURE. A CORONARY ANGIOGRAM WAS COMPLETED AFTERWARDS. FOLLOWING THE ABLATION, THE PATIENT BECAME HYPOTENSIVE. BLOOD WAS

  Patient problems: Death

  MAUDE report 9566604 ↗
• DeathJan 7, 2020Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  (B)(4). DESCRIPTION PROVIDED BY DISTRIBUTOR: AN ADVERSE EVENT REPORT WAS RECEIVED, IN WHICH YOUR DEVICE WAS INVOLVED. EVENT DESCRIPTION: DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PLEURAL EFFUSION, CARDIAC ARREST AND SUBSEQUENT DEATH OCCURRED. WHILE ATTEMPTING EPICARDIAL ACCESS, A PLEURAL EFFUSION WAS CONFIRMED ON ICE AT THE RV APEX, SUGGESTIVE PERFORATION FROM THE PAJUNK NEEDLE. EPICARDIAL ACCESS WAS CONFIRMED WITH DYE VISUALIZED LAYERING AROUND THE PERICARDIAL SPACE. A WIRE WAS THEN ADVANCED AND OBSERVED TO CURL IN THE EPICARDIAL SPACE WITHOUT ADVANCING BEYOND THE CARDIAC SILHOUETTE. AN AGILIS SHEATH WAS THEN ADVANCED OVER THE WIRE INTO THE PERICARDIAL SPACE. A SECOND WIRE WAS ADVANCED INTO THE EPICARDIUM. THE AGILIS WAS REMOVED AND ADVANCED OVER ONE OF THE WIRES. THE WIRE AND DILATOR WERE FROM THE AGILIS AND THE REMAINING WIRE WAS SECURED TO THE DRAPE. APPROXIMATELY 290 CC OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. THE EFFUSION DID NOT REACCUMULATE AND WAS CLOSELY MONITORED DURING THE PROCEDURE. A CORONARY ANGIOGRAM WAS COMPLETED AFTERWARDS. FOLLOWING THE ABLATION, THE PATIENT BECAME HYPOTENSIVE. BLOOD WAS VISUALIZED IN THE PERICARDIAL SPACE. CHEST COMPRESSIONS

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9556364 ↗