VASCU-PICC® MRVSP26001 (UDI 00884908163391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884908163391), received between Apr 27, 2022 and Sep 15, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Leak/Splash

  PICC lime was noted to be leaking and had drainage at insertion site. Dressing change was done and line was flushed. Drainage and leakage was again noted. Line attempted to be removed and resistance was noted. Physician came to remove line. It was flushed and catheter noted to be broken. Patient experienced mild Peripheral Intravenous Infiltration and Extravasation (PIVIE).

  Patient problems: Extravasation; Infiltration into Tissue

  MAUDE report 50778030 ↗
• MalfunctionMay 4, 2026Leak/Splash

  THE CATHETER WAS LEAKING FROM THE INSERTION SITE. UPON REMOVAL, IT WAS DISCOVERED THAT THE PICC WAS SPLIT AT APPROXIMATELY THE 7CM MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25066903 ↗
• MalfunctionJan 15, 2025Fracture; Fracture

  INTRAVENOUS THERAPY TO BEDSIDE TO PLACE NEW PICC TO REPLACE CURRENT LINE WITH SUSPECTED BREAK, ONCE PICC LINE SUCCESSFULLY PLACED. CENTRAL INTENSIVE CARE UNIT'S NURSE PRACTITIONER DISCHARGED RIGHT ARM PICC AND OBVIOUS LARGE FRACTURE IDENTIFIED.

  Patient problems: Insufficient Information

  MAUDE report 21157301 ↗
• MalfunctionOct 4, 2024Leak/Splash; Leak/Splash

  RED LUMEN OF THE PICC WAS CLOTTED, ALTEPLASE WAS INSTILLED FOR ABOUT 2 HOURS. NNP FLUSHED THE LUMEN AND ANOTHER ROUND OF ALTEPLASE WAS TO BE ORDERED. BEFORE THEN RNC TO BEDSIDE TO VISUALIZE THE PICC LINE SITE. THERE WAS FLUID UNDER THE DRESSING AT THE INSERTION SITE. RNC FLUSHED RED LUMEN AND VISUALIZED THE FLUSH COMING OUT FROM THE INSERTION SITE. WHEN FLUSHED AGAIN THE RED LUMEN LEAKED OUT FROM THE INSERTION SITE AND THE SITE PUFFED UP SLIGHTLY. LINE ORDERED TO BE DISCONTINUED.

  Patient problems: Swelling/ Edema

  MAUDE report 20373817 ↗
• MalfunctionJun 19, 2024Leak/Splash; Leak/Splash

  THE PICC WAS INSERTED (B)(6) 2024 AND, ON (B)(6) 2024, IT WAS REPORTEDLY LEAKING AT THE INSERTION SITE. UPON FURTHER INSPECTION BY AN IV RN, THERE WAS REPORTEDLY A CLEAR HOLE IN THE CATHETER AT THE INSERTION SITE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566335 ↗
• MalfunctionApr 6, 2023Leak/Splash; Leak/Splash

  A LEAK WAS NOTED AT THE JUNCTION OF THE RED EXTENSION AND THE CATHETER HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689098 ↗
• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  BEDSIDE NURSE PERFORMING ASSESSMENT AND NOTED BLEEDING FROM DRESSING. UPON FURTHER INVESTIGATION NOTED LEAKING FROM CATHETER UNDER DRESSING. CATHETER IMMEDIATELY REMOVED FOR PATIENT SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520579 ↗
• MalfunctionApr 27, 2022Break; Break

  PICC INFILTRATION/ SWELLING NOTED AND WET DRESSING. HOLE IN THE WHITE LEUMEN UNDER THE 1 CM BUT ABOVE THE HUB. NEW LINE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219307 ↗