STREAMLINE™ 6495FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169310100), received between Jul 19, 2021 and Jan 14, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Break; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS MYOCARDIAL TEMPORARY PACING LEAD, IT WAS REPORTED THAT THE CONNECTOR PINS CONNECTED TO THE PACING CABLE HAD BROKEN. IT WAS THEN REPORTED THAT THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24073307 ↗
• MalfunctionOct 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS TEMPORARY PACING WIRE, IT WAS REPORTED THAT THERE WAS A HAIR OBSERVED INSIDE THE STERILE PACKAGING. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556444 ↗
• MalfunctionJul 1, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS MYOCARDIAL TEMPORARY PACING LEAD, IT WAS REPORTED THAT THE LEAD WAS BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645633 ↗
• MalfunctionJul 1, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS MYOCARDIAL TEMPORARY PACING LEAD, IT WAS REPORTED THAT THE LEAD WAS BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645622 ↗
• MalfunctionJul 1, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS MYOCARDIAL TEMPORARY PACING LEAD, IT WAS REPORTED THAT THE LEAD WAS BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645606 ↗
• MalfunctionJul 1, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS MYOCARDIAL TEMPORARY PACING LEAD, IT WAS REPORTED THAT THE LEAD WAS BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645585 ↗
• MalfunctionJul 1, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS MYOCARDIAL TEMPORARY PACING LEAD, IT WAS REPORTED THAT THE LEAD WAS BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645578 ↗
• MalfunctionJul 19, 2021Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE INITIAL IMPLANT OF THIS TEMPORARY PACING LEAD, THE LEAD WAS INSERTED INTO THE PATIENTS CHEST WALL, AND ONE OF THE ELECTRODES BROKE OFF OF THE LEAD AND REMAINED INSIDE THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12187622 ↗