WEBSTER D610DRP10RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835000238), received between Feb 9, 2018 and Sep 11, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) CARDIAC ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND DURING THE OPERATION, THE TIP OR SPLINES OF THE CATHETER WAS FOUND BENT (NO EXPOSED WIRES). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726512 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND A BROKEN TIP ISSUE OCCURRED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE CATHETER WAS FOUND BENT, AND WIRE WAS EXPOSED. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285960 ↗
• MalfunctionDec 30, 2021Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND AN ISSUE OF FOREIGN MATERIAL WAS ENCOUNTERED. AN ISSUE OF FOREIGN MATTER WAS REPORTED ALONG WITH WHAT WAS DESCRIBED AS A ¿PROTRUSION¿ ON THE DISTAL TIP OF THE CATHETER. HOWEVER, REVIEW OF A PHOTO PROVIDED, IT WAS DETERMINED THAT THE PROTRUSION WAS ACTUALLY THE DEVICE¿S ANCHOR WINDOW AND NOT A PROTRUSION. THE ANCHOR WINDOW IS PART OF THE CATHETER¿S DESIGN. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT CONSEQUENCE SINCE THE DEVICE WAS NOT USED IN THE PATIENT. THIS EVENT IS CONSIDERED MDR REPORTABLE FOR THE FOREIGN MATTER ISSUE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13121586 ↗
• MalfunctionFeb 9, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A WEBSTER CATHETER AND A BROKEN TIP WITH INTERNAL COMPONENT EXPOSURE OCCURRED DURING THE PROCEDURE. THE CATHETER WAS CHANGED AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT IS MDR REPORTABLE BECAUSE IF THE CATHETER INTEGRITY IS NOT MAINTAINED THERE IS A POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7259927 ↗