Vascu-PICC® MR170126024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00884908105131), received between May 7, 2019 and Dec 8, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  THE PHYSICIAN INSERTED THE PICC INTO A PATIENT. AFTER WHICH LEAKAGE WAS OBSERVED. IN AN ATTEMPT TO REPLACE IT, THEY INTRODUCED A GUIDEWIRE INTO THE LEAKING PICC AND TRIED TO INSERT A NEW LINE OVER THE WIRE. IT'S UNCLEAR WHETHER THE DEFECT (A HOLE IN THE PICC) WAS PRESENT INITIALLY AND CAUSED THE LEAK OR WHETHER IT OCCURRED DURING THE GUIDEWIRE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742720 ↗
• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT'S GRANDMOTHER TOLD THE NURSE THAT SHE HAD HELPED THE PATIENT UP AND SAW THAT THE INFUSION HAD FALLEN TO THE FLOOR. WHEN THE NURSE CAME INTO THE ROOM, THE WHITE WING/TRIANGLE OF THE PICC LINE TUBE HAD BROKEN OFF/SLIPPED OUT. IT HAD BLED OUT TO THE PICC LINE AND THE INFUSION WITH THE WHITE WING WAS LYING ON THE FLOOR. THE FOIL ON THE PUNCTURE SITE WAS STILL HOLDING WELL, THE GRIPLOCK WAS LOOSE. THE DOCTORS WERE INFORMED AND THE PICC LINE WAS COMPLETELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148810 ↗
• MalfunctionDec 2, 2024Break; Break

  PATIENT'S BED IS WET, NURSE LOOKS FOR THE TRIGGER. IT BECOMES APPARENT THAT THE PERIPHERAL CVC IS TORN APART. CHILD WAS ASLEEP, THERE WAS NO MANIPULATION OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819374 ↗
• MalfunctionDec 2, 2024Break; Break

  CATHETER IS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817822 ↗
• MalfunctionJul 24, 2024Break; Break

  DURING THE MOBILIZATION OF A PATIENT, THE PICC BROKE APART AT THE CONNECTION POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816690 ↗
• MalfunctionMay 6, 2024Leak/Splash; Leak/Splash

  A LEAK FROM ONE OF THE LUMENS FROM A HOLE IN THROUGH THE LUMEN DISTAL TO THE HUB. WE NOTICED THIS PROBLEM 2 DAYS AFTER THE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246983 ↗
• MalfunctionApr 30, 2024Break; Break

  DIFFICULT PICC INSERTION. AFTERWARDS ALMOST NOT FLUSHABLE, THEN HIGH RUN RATE. TORN OFF DURING MOVEMENT OF THE CHILD. PICC COULD COMPLETELY BE REMOVED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213672 ↗
• MalfunctionMar 11, 2024Break; Break

  PICC WAS FIXED BY DEFAULT BUT WAS DISCONNECTED AT THE CATHETER CONNECTION POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875762 ↗
• InjuryFeb 20, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  INFUSOTHORAX ON THE LEFT WITH DISLOCATED PICC. PARENTERAL NUTRITION LEAKED INTO THE PLEURAL CAVITY, RESPIRATORY COMPROMISE, PLEURAL PUNCTURE NECESSARY AND RESPIRATORY SUPPORT WITH CPAP.

  Patient problems: Pleural Effusion; Respiratory Insufficiency

  MAUDE report 18739503 ↗
• MalfunctionJun 16, 2023Leak/Splash; Leak/Splash

  DEVICE WAS PLACED UNDER FLUOROSCOPY ON (B)(6) 2023. DURING NIGHT SHIFT ON (B)(6) 2023 A LEAK WAS DISCOVERED DURING FLUSHING. THE PICC HAS A HOLE NEAR THE CATHETER WING IN THE PATIENT'S VEIN. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143229 ↗
• MalfunctionJun 16, 2023Leak/Splash; Leak/Splash

  DEVICE WAS PLACED UNDER FLUOROSCOPY. A LEAK WAS DISCOVERED DURING FLUSHING. THE PICC HAS A HOLE IN THE CATHETER LUMEN IN THE PATIENT'S VEIN. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142978 ↗
• MalfunctionNov 28, 2022Break; Break

  A HOLE WAS NOTED IN THE WHITE LUMEN. THE HOLE IS BETWEEN THE CATHETER LUMEN AND CATHETER WING. CATECHOLMINE THERAPY COULD NOT BE ADEQUATELY ADMINISTERED AND THE PATIENT SHOWED INCREASING SIGNS OF HEART FAILURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15868429 ↗
• MalfunctionMay 7, 2019Leak/Splash; Leak/Splash

  WHEN THE CATHETER WAS FLUSHED, THE LINE WAS LEAKING AT THE INSERTION SITE. IT APPEARS THAT THE LUMEN HAD BURST. CATHETER WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587135 ↗