BARD Latex-free Arterial Embolectomy Catheters CE0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915117412), received between Mar 6, 2017 and Mar 6, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "IT WAS REPORTED THAT THREE CATHETERS WERE INTRODUCED INTO THE A.POPLITEA P3 WITHOUT A INTRODUCER SHEAT. DURING INFLATION, THE BALLOON BURST AFTER 3-4 SECONDS. AS IT WAS EXPECTED THAT THE CALCIFICATION OF THE VESSEL WAS THE ROOT COURSE, THE CUSTOMER TRIED TO INFLATE THE BALLOON OUTSIDE THE PATIENT'S BODY. EVEN WITHOUT NEGATIVE PRESSURE THE BALLOON BURST AFTER 3-4 SECONDS." PATIENT STATUS - PATIENT IS GOING WELL, NO PROBLEMS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382140 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "IT WAS REPORTED THAT THREE CATHETERS WERE INTRODUCED INTO THE A.POPLITEA P3 WITHOUT A INTRODUCER SHEAT. DURING INFLATION THE BALLOON BURST AFTER 3-4 SECONDS. AS IT WAS EXPECTED THAT THE CALCIFICATION OF THE VESSEL WAS THE ROOT COURSE, THE CUSTOMER TRIED TO INFLATE THE BALLOON OUTSIDE THE PATIENT'S BODY. EVEN WITHOUT NEGATIVE PRESSURE THE BALLOON BURST AFTER 3-4 SECONDS." PATIENT STATUS - PATIENT IS GOING WELL, NO PROBLEMS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382136 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "IT WAS REPORTED THAT THREE CATHETERS WERE INTRODUCED INTO THE A.POPLITEA P3 WITHOUT A INTRODUCER SHEAT. DURING INFLATION THE BALLOON BURST AFTER 3-4 SECONDS. AS IT WAS EXPECTED THAT THE CALCIFICATION OF THE VESSEL WAS THE ROOT COURSE, THE CUSTOMER TRIED TO INFLATE THE BALLOON OUTSIDE THE PATIENT'S BODY. EVEN WITHOUT NEGATIVE PRESSURE THE BALLOON BURST AFTER 3-4 SECONDS." PATIENT STATUS - PATIENT IS GOING WELL, NO PROBLEMS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382135 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "IT WAS REPORTED THAT THREE CATHETERS WERE INTRODUCED INTO THE A.POPLITEA P3 WITHOUT A INTRODUCER SHEAT. DURING INFLATION THE BALLOON BURST AFTER 3-4 SECONDS. AS IT WAS EXPECTED THAT THE CALCIFICATION OF THE VESSEL WAS THE ROOT COURSE, THE CUSTOMER TRIED TO INFLATE THE BALLOON OUTSIDE THE PATIENT'S BODY. EVEN WITHOUT NEGATIVE PRESSURE THE BALLOON BURST AFTER 3-4 SECONDS." PATIENT STATUS - PATIENT IS GOING WELL, NO PROBLEMS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382130 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "IT WAS REPORTED THAT THREE CATHETERS WERE INTRODUCED INTO THE A.POPLITEA P3 WITHOUT A INTRODUCER SHEAT. DURING INFLATION THE BALLOON BURST AFTER 3-4 SECONDS. AS IT WAS EXPECTED THAT THE CALCIFICATION OF THE VESSEL WAS THE ROOT COURSE, THE CUSTOMER TRIED TO INFLATE THE BALLOON OUTSIDE THE PATIENT'S BODY. EVEN WITHOUT NEGATIVE PRESSURE THE BALLOON BURST AFTER 3-4 SECONDS." PATIENT STATUS - PATIENT IS GOING WELL, NO PROBLEMS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382129 ↗