VASCU-PICC® MD17012601 (UDI 00884908142167)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884908142167), received between Jan 27, 2026 and Sep 24, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Leak/Splash

  PICC dressing noted to have drainage so primary RN asked for assistance changing dressing. Once old, soiled dressing was taken down, leaking noted to be coming from actual catheter and not from insertion site. MD notified and PICC removed. PICC team attempted to get a new PICC line but was unable to see a vein that she felt comfortable using. PIV placed instead. Brusing noted around the insertion site. Once PICC removed, further inspection confirmed that there was a hole in actual catheter originating from the white lumen (lumen that had sedation and pressors infusing).

  Patient problems: Bruise/Contusion

  MAUDE report 50884329 ↗
• InjuryJul 31, 2026Leak/Splash

  This event involves a patient who was admitted to "[redacted]" Pediatric Intensive Care Unit (PICU) on "[redacted]" from an outside hospital for surgical management. On "[redacted]"-the day of admission, the patient underwent surgery for an open external incision and drainage of the retropharyngeal and mediastinal abscess via the left neck. On "[redacted]"-post-op day 1, the patient underwent a bedside procedure to insert a peripherally inserted central catheter (PICC) in the right upper extremity for antibiotic therapy without complication.On "[redacted]"-post-op day 7, the patient demonstrated wincing when the white port of the PICC line was flushed as per routine. Initially a 10 cubic centimeter (cc) syringe was used to flush the port but was met with resistance. A second attempt was made to flush the port with a 3cc syringe that was filled with heparin prior to flushing. The patient continued to wince, and leaking was noted at the insertion site. An Intravenous Team (IV) nurse was consulted to evaluate the site. Assessment of the PICC also indicated that the red port was not flushing. A decision was made to discontinue use of the line and to remove the PICC. On "[redacted]"-pos

  Patient problems: Pain

  MAUDE report 50096990 ↗
• InjuryJul 31, 2026Leak/Splash

  This event involves a patient who was admitted to "[redacted]" Pediatric Intensive Care Unit (PICU) on "[redacted]" from an outside hospital for monitoring and management. On "[redacted]"-hospitalization day #45, the 2.6 Fr picc line was found cracked at the hub when the PICC RN came to assess and administered a tissue plasma activator (TPA), which is a thrombolytic agent, to the line. The TPA was administered to both lumens but after the dwell both lumens were still very sluggish with no blood return. The dressing was removed to further investigate and was found to be wet underneath. The line was then flushed with the dressing off and leaking was visible from catheter. On "[redacted]"-hospitalization day #47 a new PICC was placed by IV RN on "[redacted]"-that day at 1123 at the bedside over a guidewire at the same site as the previous PICC and midline. PICC breakage a result of user error, not device failure although there were still concerns regarding the product by the team.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096989 ↗
• MalfunctionFeb 27, 2026Fracture

  PICC LINE FRACTURE WHICH IS NON-REPAIRABLE. WILL NEED TO BE REPLACED, EXCHANGED UNDER CARDIAC ANEESTHESIA SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471158 ↗
• MalfunctionJan 27, 2026Leak/Splash

  AT 1600 RN RETURNS PATIENT TO BED FROM MOMS' ARMS AFTER DRAWING BLOOD FROM PICC LINE AND CSF FROM EVD. MOM NOTICES A WET SPOT ON HER SHIRT LEADING TO THE DISCOVERY OF A NEWLY INFILTRATED LUE PICC. THIS LINE WAS PLACED (B)(6). FAULTY LINE REMOVED FROM PT. NEW PICC PLACED BY PICC TEAM SUCCESSFULLY AND CONFIRMED BY XRAY.

  Patient problems: Extravasation

  MAUDE report 24187815 ↗