VASCU-PICC® MD17012600 (UDI 00884908180183)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884908180183), received between Sep 9, 2025 and May 26, 2026 — classified as 6 malfunctions.

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

• MalfunctionMay 26, 2026Leak/Splash

  THE NURSE WAS PLACING A PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE IN PATIENT AS ORDERED. THE PATIENT WAS PREPPED AND A 3 FRENCH 5CM INTRODUCER/DILATOR WAS INSERTED WITHOUT ISSUE. A 2.6 FRENCH DOUBLE LUMEN PICC WAS THEN OPENED AND ADVANCED THROUGH THE INTRODUCER WITHOUT RESISTANCE. WHILE FLUSHING THE PICC TO CHECK FOR PATENCY, THE RED LUMEN WAS NOTED TO BE LEAKING AT THE INSERTION SITE. THE WHITE LUMEN REMAINED INTACT. A DEFECT OF THE PICC LINE WAS IDENTIFIED AND THE LINE WAS REMOVED AND REPLACED WITH ANOTHER 2.6 FRENCH DOUBLE LUMEN PICC OF THE SAME LOT NUMBER. NO LEAKING WAS NOTED IN EITHER LUMEN OF THE SECOND PICC LINE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278941 ↗
• MalfunctionApr 27, 2026Leak/Splash

  FLUSHING BOTH SIDES RESULTED IN A LUMEN LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997819 ↗
• MalfunctionMar 4, 2026Leak/Splash

  INSERTING PICC AND NOTICED FLUID COMING OUT OF THE CATHETER AROUND THE 3 CM MARK. IT APPEARS THERE IS A SMALL HOLE IN THE CATHETER. PICC WAS REMOVED AT THE TIME OF INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508157 ↗
• MalfunctionDec 1, 2025Flushing Problem; Leak/Splash; Flushing Problem; Leak/Splash

  RN'S HAVE EXPERIENCED DIFFICULTY IN THE PAST 24 HOURS WITH FLUSHING AND WITHDRAWING BLOOD FROM THE RED LUMEN OF PATIENT'S 2.6F PICC CATHETER. PATIENT NOW COMPLAINING OF PAIN AT INSERTION SITE WHEN ATTEMPTS AT FLUSHING THE RED LUMEN OCCUR. BEDSIDE RN NOTIFIED ATTENDING MD AND RED LUMEN TO NO LONGER BE USED AT THIS TIME. IVT CONSULTED. IR CONSULT PLACE AND PLAN FOR PATIENT TO GET LINE RE-WIRED/REPLACED.

  Patient problems: Pain

  MAUDE report 23683928 ↗
• MalfunctionDec 1, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681188 ↗
• MalfunctionSep 9, 2025Leak/Splash; Leak/Splash

  WHEN PERFORMING AN OVER THE WIRE ON THE PATIENT PHYSICIAN WAS ABLE TO THREAD THE WIRE INTO THE LINE BUT WHEN IT WAS TIME TO PULL THE LINE OUT, A POP WAS FELT AND THE LINE COULD NOT BE PULLED UNLESS BOTH THE GUIDE WIRE AND THE LINE WERE PULLED. THE RESULT WAS LOSS OF ACCESS AND PARENTS REFUSED TO HAVE A NEW PICC PLACED IN ANOTHER LIMB AT THIS TIME. WHEN THE MOTHER WAS, SHE DID STATE THAT WHEN THEY HAD BEEN DISCHARGED AND SHE FLUSHED THE LINE AND FELT A POP. PRIOR TO OVER THE WIRING THE LINE IT WAS NOTICED THAT THE LINE WAS LEAKING AND MOST LIKELY HAD A RUPTURE IN THE LINE PRIOR TO THE OVER THE WIRE WAS ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003256 ↗