VASCU-PICC® MD170126024S (UDI 00884908147230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884908147230), received between Oct 13, 2020 and Nov 26, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  BABY HAD A LEFT HEMITHORAX, TESTED THE PLEURAL FLUID AND IT HAS TRIGLYCERIDES AND GLUCOSE CONSISTENT WITH A L HEMITHORAX. CHEST TUBE WAS PLACED AFTER CLINICAL DECOMPENSATION. TEAM SUSPECTED POTENTIAL INFILTRATION OF TPN/LIPIDS FROM PICC. PICC WAS D/C'D AND TPN WAS STOPPED AND CHEST TUBE OUTPUT IMMEDIATELY STOPPED. CLINICAL DECOMPENSATION, HAS NOW IMPROVED AND WAS EXTUBATED.

  Patient problems: Insufficient Information

  MAUDE report 20787811 ↗
• MalfunctionApr 28, 2023Leak/Splash; Leak/Splash

  PLACED THE PICC A FEW DAYS PRIOR TO THE REPORTED EVENT. CALL FROM THE PICU WITH THE CONCERN THAT THE LINE WAS LEAKING. THE PATIENT'S ARM WAS SWOLLEN AND THE PICC WAS NOT ASPIRATING. THE PICC WAS ASSESSED IT, AND EXPERIENCED AIR UPON ASPIRATION FROM THE HUBS. THE LINE WAS REMOVED BY THE NURSE AND NOTED TO HAVE SIGNIFICANT COMPROMISE.

  Patient problems: Swelling/ Edema

  MAUDE report 16833032 ↗
• MalfunctionOct 31, 2022Leak/Splash; Leak/Splash

  PICC PLACED UNGENTLY EARLIER IN THE DAY. WHITE LUMEN USED FOR INTERMITTENT MEDICATIONS PER STAFF NURSE, FOUND LEAKING. ATTEMPTED PICC RE-WIRE/EXCHANGE UNSUCCESSFULLY BY 2 VAS NURSED RESULTING IN LOSS OF LINE AS NOTHING WOULD THREAD. UPON INSPECTION OF LINE, NOTED TO HAVE RUPTURED 1-1.5CM FROM HUB OF WHITE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698927 ↗
• MalfunctionSep 29, 2022Break; Break

  A NURSE REPORTED AN ISSUE WITH A VASCU-PICC TLS PEDIATRIC 2.6FX50CM DL MST KIT. IT WAS REPORTED THAT AFTER INDWELL OF THE DEVICE, IT WAS NOTICED THE CATHETER BALLOONED IN TWO LOCATIONS, CAUSING LEAKAGE. ONE BALLOON ON THE CATHETER WAS INTERNAL AND ONE WAS EXTERNAL. THIS RESULTED IN A LEAK AND POSITIVE INFECTION CULTURE. THE PATIENT THEN HAD A CVC PLACED, AND THEN A NEW PICC LINE WAS PLACED. THE PATIENT WAS REPORTED AS STABLE POST EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504499 ↗
• MalfunctionSep 28, 2022Break; Break

  POST PROCEDURE, 1.5CM WAS EXPOSED AT THE INSERTION SITE. THE CATHETER REPORTEDLY BALLOONED/ HAD A HOLE IN IT AT THE 1CM MARK, EXTERNAL TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495851 ↗
• MalfunctionSep 16, 2022Break; Break

  CATHETER BALLOONED AND HAD A HOLE AT APPROXIMATELY 3.5CM CAUSING A LEAK. SEDATION WAS BEING GIVEN THROUGH THE LINE THROUGH THE PICC LINE, RESULTING IN THE PATIENT COMING OUT OF SEDATION AGGRESSIVELY. LINE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439776 ↗
• MalfunctionJul 21, 2022Break; Break

  AN END USER REPORTED AN ISSUE WITH A VASCU-PICC TLS PEDIATRIC 2.6FX50CM DL MST KIT, THAT WAS PLACED INTO A PATIENT IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THREE DAYS AFTER PICC PLACEMENT, THE NICU NOTICED A RIGHT FEMORAL EXTRAVASATION OF 61%. WHEN IR ARRIVED TO REMOVE THE LINE AND PLACE A NEW ONE, A LONGITUDINAL SPLIT ALONG THE CATHETER WAS NOTED. THE DEVICE RELATED FAILURE WAS REPORTED TO HAVE LED TO PATIENT HARM.

  Patient problems: Extravasation

  MAUDE report 15078887 ↗
• MalfunctionApr 27, 2022Break; Break

  DRESSING WAS WET (NO INDICATION IN CHART- JUST SAID POSSIBLE DISPLACEMENT IN THE EVENT NOTE) THEN AN ORDER TO REPLACE THE LINE. THE HOLE WAS JUST ABOVE THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219144 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE DAY AFTER INSERTION, FEMORAL VEIN, IT WAS NOTED THE DRESSING WAS SATURATED AND THE PICC WAS LEAKING. AFTER REMOVAL IT WAS NOTED THERE WERE 1 OR TWO POSSIBLE HOLES JUST DISTAL TO THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460073 ↗
• MalfunctionAug 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A LEAK WAS NOTED COMING FROM THE INSERTION SITE THAT WOULD SOAK THE DRESSING AND LINENS SURROUNDING THE PATIENT. THE LINE WAS EXCHANGED AND AFTER INSPECTING IT, THERE IS A PIN HOLE LEAK THAT IS DISTAL TO THE HUB THAT WOULD BE JUST INSIDE THE PATIENT. IT CANNOT BE SEEN WITH THE NAKED EYE BECAUSE IT IS TOO SMALL BUT WHILE FLUSHING SALINE, THERE IS A NOTABLE LEAK COMING FROM THERE. ON THE CUT INTERNAL PORTION, IT WAS NOTED THAT THERE SEEMED TO BE A CLOT WITHIN THE TUBE. FACILITY CONSIDERED MAYBE IT WAS MORE OF A MAINTENANCE ISSUE THAN A PRODUCT ISSUE AT THIS POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385824 ↗
• MalfunctionOct 13, 2020Leak/Splash; Leak/Splash

  NURSING NOTICED SWELLING, PATIENT PAIN, DISCOMFORT WHEN PICC USED. PATIENT BROUGHT TO VIR FOR PICC EXCHANGE. UPON REMOVAL THE DEVICE WAS NOTED TO HAVE CRACKED.

  Patient problems: Pain; Swelling

  MAUDE report 10671448 ↗