BARD Latex-free Arterial Embolectomy Catheters CE0480Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915117504), received between Mar 6, 2017 and Mar 6, 2017 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 6 most recent of 6 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 - "CUSTOMER COMPLAINED THAT THE BALLOON BURST DURING DILATATION. REPORTEDLY THE CUSTOMER USED 6 CATHETER DURING ONE PROCEDURE AS EACH BALLOON BURST. NO SAMPLES AVAILABLE FOR RETURN, DISCARDED BY THE USER FACILITY. CUSTOMER = (B)(6)." PATIENT STATUS - "NO PATIENT INJURY REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382156 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "CUSTOMER COMPLAINED THAT THE BALLOON BURST DURING DILATATION. REPORTEDLY, THE CUSTOMER USED 6 CATHETER DURING ONE PROCEDURE AS EACH BALLOON BURST. NO SAMPLES AVAILABLE FOR RETURN, DISCARDED BY THE USER FACILITY. CUSTOMER = (B)(6)." PATIENT STATUS - "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382155 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "CUSTOMER COMPLAINED THAT THE BALLOON BURST DURING DILATATION. REPORTEDLY THE CUSTOMER USED 6 CATHETER DURING ONE PROCEDURE AS EACH BALLOON BURST. NO SAMPLES AVAILABLE FOR RETURN, DISCARDED BY THE USER FACILITY. CUSTOMER = (B)(6)." PATIENT STATUS - "NO PATIENT INJURY REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382154 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "CUSTOMER COMPLAINED THAT THE BALLOON BURST DURING DILATATION. REPORTEDLY, THE CUSTOMER USED 6 CATHETER DURING ONE PROCEDURE AS EACH BALLOON BURST. NO SAMPLES AVAILABLE FOR RETURN, DISCARDED BY THE USER FACILITY. CUSTOMER = (B)(6)." PATIENT STATUS - "NO PATIENT INJURY REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382153 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "CUSTOMER COMPLAINED THAT THE BALLOON BURST DURING DILATATION. REPORTEDLY, THE CUSTOMER USED 6 CATHETER DURING ONE PROCEDURE AS EACH BALLOON BURST. NO SAMPLES AVAILABLE FOR RETURN, DISCARDED BY THE USER FACILITY. CUSTOMER = (B)(6)." PATIENT STATUS - "NO PATIENT INJURY REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382152 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED UNKNOWN - "CUSTOMER COMPLAINED THAT THE BALLOON BURST DURING DILATATION. REPORTEDLY THE CUSTOMER USED 6 CATHETER DURING ONE PROCEDURE AS EACH BALLOON BURST. NO SAMPLES AVAILABLE FOR RETURN, DISCARDED BY THE USER FACILITY. CUSTOMER = (B)(6)." PATIENT STATUS - "NO PATIENT INJURY REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382151 ↗