Flowguard™ 10730-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821329400155), received between Jul 22, 2016 and Aug 31, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2016Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE LEAD IMPLANT PROCEDURE, WHILE ADVANCING THE LEAD THROUGH THE INTRODUCER, IT BECAME DIFFICULT TO MANEUVER AND THE DR. SPLIT THE INTRODUCER. WHEN THE INTRODUCER WAS SPLIT THE VALVE CAME LOOSE FROM THE SHEATH. THE SHEATH WAS JUST VISIBLE IN THE V. CEPHALICA AND THE DR. WAS ABLE TO GRAB THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5917482 ↗
• MalfunctionJul 22, 2016Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE LEAD IMPLANT PROCEDURE, WHILE ADVANCING THE LEAD THROUGH THE INTRODUCER, THE SHEATH HANDLE WITH THE VALVE BROKE OFF THE SHEATH TUBE AND THE LEAD CAME OUT THROUGH THE VALVE. THE SHEATH TUBE DISAPPEARED IN THE VENOUS SYSTEM (VIA THE SUBCLAVIAN VEIN) AND COULD NOT BE RETRIEVED INITIALLY. THE SHEATH TUBE WAS REMOVED FROM THE VENOUS SYSTEM VIA THE GROIN (FEMORAL VEIN) USING A BIOPTOME AND A SNARE. THE PROCEDURE WAS CANCELLED AND THE PATIENT NEEDS TO UNDERGO ANOTHER IMPLANT PROCEDURE. AT THE TIME OF THE INCIDENT NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5815218 ↗