ENVOY 670-256-90BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704031727), received between Jun 14, 2017 and Jun 15, 2017 — classified as 3 malfunctions.

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

• MalfunctionJun 15, 2017Split; Physical Resistance; Split; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL AN ENVOY CATHETER (67025690B/ 17641208) WOULD NOT ADVANCE UP THE CORDIS SHEATH, AND WHEN IT COULD ADVANCE IT WAS STIFF AND CAUSED THE ENVOY TO BREAK (CRACKED/SPLIT) AT THE DISTAL TIP. THE SAME ISSUE OCCURRED 2 DAYS RUNNING (ADDITIONAL COMPLAINT ADDED). THIS HOSPITAL HAS USED THE SAME SETUP INCLUDING THE CATHETER AND SHEATH AND HAS HAD THIS ISSUE OCCUR A FEW TIMES IN THE LAST CALENDAR YEAR; HOWEVER, ALL COMPLAINTS WERE REPORTED TO THE MANUFACTURER. THE DEVICE WAS USED AS PER THE IFU, AND A FLUSH HAD BEEN MAINTAINED. IT WAS REPORTED THAT THE CATHETER AND SHEATH WAS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644942 ↗
• MalfunctionJun 15, 2017Split; Physical Resistance; Split; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL AN ENVOY CATHETER (67025690B/ 17641208) WOULD NOT ADVANCE UP THE CORDIS SHEATH, AND WHEN IT COULD ADVANCE IT WAS STIFF AND CAUSED THE ENVOY TO BREAK (CRACKED/SPLIT) AT THE DISTAL TIP. THE SAME ISSUE OCCURRED 2 DAYS RUNNING (ADDITIONAL COMPLAINT ADDED). THIS HOSPITAL HAS USED THE SAME SETUP INCLUDING THE CATHETER AND SHEATH AND HAS HAD THIS ISSUE OCCUR A FEW TIMES IN THE LAST CALENDAR YEAR; HOWEVER, ALL COMPLAINTS WERE REPORTED TO THE MANUFACTURER. THE DEVICE WAS USED AS PER THE IFU, AND A FLUSH HAD BEEN MAINTAINED. IT WAS REPORTED THAT THE CATHETER AND SHEATH WAS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644869 ↗
• MalfunctionJun 14, 2017Split; Split

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ENVOY CATHETER (67025690B/ 17641208) WOULD NOT ADVANCE UP THE CORDIS SHEATH. WHEN IT COULD ADVANCE, IT WAS STIFF AND CAUSED THE ENVOY TO SPLIT/CRACK AT THE TIP. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6642240 ↗