PowerHohn Catheter for Central Venous Placement AVA33861Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741036835), received between Feb 25, 2022 and Feb 25, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "MY CUSTOMER LET ME KNOW OF A LEAKING POWERHOHN UPON INSERTION EARLIER TODAY. IT WAS LEAKING AT THE SUTURE WING RIGHT OUT OF THE BOX. IT WAS PLACED IN A PATIENT, DREW BLOOD, AND WHEN THEY WENT TO FLUSH THEY STATED THAT FLUID SHOT OUT OF THAT AREA." ADDITIONAL INFO. RECEIVED 02.11.2022: "LEFT IJ INSERTION OF THE 6FR TRIPLE LUMEN HOHN CATH. LINE INSERTION WENT GREAT AND ON FINAL BLOOD RETURN CHECK AND FLUSH, I NOTICED THAT THE LINE WAS LEAKING WHERE THE SUTURE WING AND LINE MEET OR CONNECT WHEN THE GRAY LUMEN WAS FLUSHED. I FLUSHED TO CONFIRM AND THE GRAY LUMEN WAS SPRAYING SALINE. I THEN OPENED ANOTHER KIT AND PREFORMED A CATH EXCHANGE FOR ANOTHER 6FR TRIPLE LUMEN POWER HOHN OF THE SAME LOT NUMBER AND THE NEW LINE DID NOT LEAK FROM ANY LUMEN. THE RED AND WHITE LUMENS DID NOT LEAK WHEN FLUSHED ONLY THE GRAY ON THE ORIGINAL LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13602558 ↗