EZ Steer DS BD7TCDF8LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835002539), received between Oct 29, 2020 and Oct 29, 2020 — classified as 2 malfunctions.

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.

• MalfunctionOct 29, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH TWO (2) A EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETERS WHEREIN PROCEDURE DELAY OCCURRED. IT WAS REPORTED BOTH EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER DIDN'T WORK. THE FIRST EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER DID NOT PROVIDE RADIOFREQUENCY DUE IMPEDANCE OFF THE SCALE. AFTER ONE HOUR OF CONNECTION CHANGES AND CONTACTS FOR ASSISTANCE, ANOTHER EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS USED THAT PRESENTED THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH A THIRD CATHETER 4 MM. THE CALLER STATED THAT THE CONSEQUENCES WERE PROCEDURE DELAY, RADIOFREQUENCY EXPOSITION, SEVERE DISCOMFORT AND VEIN THROMBOSIS RISK. THERE IS NO REPORT OF PATIENT CONSEQUENCE. SINCE THE CALLER CONSIDERED THE DELAY TO INCREASE RISK OF THROMBOSIS IT IS CONSIDERED MDR REPORTABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SHOULD MORE INFORMATION BECOME AVAILABLE IN THE FUTURE; THE REPORTABILITY DECISION WILL BE REASSESSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10757154 ↗
• MalfunctionOct 29, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH TWO (2) A EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETERS WHEREIN PROCEDURE DELAY OCCURRED. IT WAS REPORTED BOTH EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER DIDN'T WORK. THE FIRST EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER DID NOT PROVIDE RADIOFREQUENCY DUE IMPEDANCE OFF THE SCALE. AFTER ONE HOUR OF CONNECTION CHANGES, AND CONTACTS FOR ASSISTANCE, ANOTHER EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS USED THAT PRESENTED THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH A THIRD CATHETER 4 MM. THE CALLER STATED THAT THE CONSEQUENCES WERE PROCEDURE DELAY, RADIOFREQUENCY EXPOSITION, SEVERE DISCOMFORT AND VEIN THROMBOSIS RISK. THERE IS NO REPORT OF PATIENT CONSEQUENCE. SINCE THE CALLER CONSIDERED THE DELAY TO INCREASE RISK OF THROMBOSIS IT IS CONSIDERED MDR REPORTABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SHOULD MORE INFORMATION BECOME AVAILABLE IN THE FUTURE, THE REPORTABILITY DECISION WILL BE RE-ASSESSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10757054 ↗