Safedraw™ 10884450544157Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450544157), received between Sep 29, 2021 and Dec 12, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionDec 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE TUBING WAS FOUND DAMAGED AND LEAKAGE FLIUD. NO INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919052 ↗
• MalfunctionOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT AFTER THE PRIMING OF THE UNIT AS USUAL BEFORE USE, IT WAS STARTED TO BE USED FOR THE PATIENT. NO LEAKAGE WAS FOUND AT THAT TIME. DURING OPERATION, HEPARINIZED SALINE LEAKED OUT FROM A BONDED JUNCTION BETWEEN A TRANSDUCER AND AN INFUSION LINE UPSTREAM. THE USER DID NOT TAP OR OVERTIGHTEN THE JUNCTION BEFORE USE. IT IS UNKNOWN WHETHER THE JUNCTION WAS ACTUALLY BONDED AND WHETHER IT HAD A CRACK. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586106 ↗
• MalfunctionSep 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING BLOOD FROM THE DEVICE TIP. THE PM SET WAS EXCHANGED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548807 ↗