Vascu-PICC® MR17012600Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00884908093711), received between Apr 18, 2018 and Feb 9, 2024 — classified as 1 death, 10 malfunctions.

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

• DeathFeb 9, 2024Migration; Migration

  PICC INSERTED AT RIGHT CEPHALIC VEIN. IT WAS TRIMMED. INITIALLY THERE WAS 1CM EXTERNAL LENGTH IMMEDIATELY AFTER INSERTION. TIP LOCATION CONFIRMED BY X-RAY. SECURED TO PATIENT WITH SECURE PORT IV TISSUE ADHESIVE AND TEGADERM. ON (B)(6) 2024 THE PICC HAD MIGRATED TO HEART. EXTERNAL LENGTH NOTED TO BE SAME AS DATE OF INSERTION (1CM). TIP POSITION VERIFIED BY X-RAY. PICC PULLED BACK/REPOSITIONED TO PATIENT'S SVC JUNCTION, SO IT WAS IN A SAFE POSITION. ADDITIONAL 1.5 CM PULLED OUT, FOR A TOTAL OF 2.5CM EXTERNAL LENGTH AFTER INTERVENTION. ON (B)(6) 2024 THE PATIENT'S PARENTS WITHDREW CARE AND PATIENT DIED. CAUSE OF DEATH: SEVERE HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675335 ↗
• MalfunctionOct 17, 2023Leak/Splash; Leak/Splash

  DRESSING NOTED TO HAVE DRAINAGE ON IT WITH FIRST CHECK, WRITER CALLED NNP TO ASSESS, DRESSING REMOVED AND PICC FLUSHED AND NNP NOTED THAT THE LINE WAS CRACKED WHERE THE LINE MEETS THE WINGS. LEAKING NOTED ON DAY SHIFT POST BLOOD TRANSFUSION. LINE REMOVED AND NEW PICC INSERTED BY NNP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950948 ↗
• MalfunctionFeb 8, 2023Break; Break

  TERM BABY RE-ADMITTED VIA EMERGENCY DEPARTMENT FOR SEPSIS. PICC INSERTED BY ANESTHESIA IN OPERATING ROOM. PICC LINE NOTED TO BE LEAKING DURING ADMINISTRATION OF ANTIBIOTIC, PULLED DRESSING BACK AND LINE CRACKED AT WINGS WHEN FLUSHED BOTH LUMENS WITH NORMAL SALINE SYRINGES. PICC INFUSING D5W 0.45% NS HEPARIN AT RATE OF 5ML/HR TKVO. AT 0900: RN ADMINISTERED AMPICILLIN VIA PUMP OVER 15 MINUTES. NOTED PICC DRESSING FELT SLIGHTLY WET ALONG THE EDGE. BOTH LUMENS HEPLOCKED POST INFUSION. RN INSPECTED AND UNABLE TO VISUALIZE FLUID UNDER DRESSING. DISCUSSED FINDINGS WITH NNP AND PARENTS MADE AWARE. DECISION MADE AT THAT TIME TO RE-ASSESS POST MRI SCHEDULED FOR THE AFTERNOON. 1400: PICC DRESSING REMOVED WITH NNP PRESENT TO ASSESS SITE. BOTH LUMENS FLUSHED AND NOTED LEAKING FROM THE LINE AT THE JUNCTION OF THE CATHETER AND THE WINGS/HUB. NNP ATTEMPTED AT THAT TIME TO RE-WIRE A NEW PICC OVER EXISTING LINE BUT WAS UNSUCCESSFUL. PICC REMOVED AND BABY GIVEN REST PERIOD PRIOR TO ATTEMPTING NEW LINE. 2ND LINE SUCCESSFULLY INSERTED 3 HOURS POST ON FIRST ATTEMPT. NO DEVIATIONS IN CARE. IN DISCUSSION WITH RN, ONLY USED 10ML PRE-FILLED SALINE SYRINGES AND HEPARIN FLUSH SYRINGES. ALL OTHER MEDICATIONS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324426 ↗
• MalfunctionJan 31, 2022Break; Break

  A CHEST X-RAY DEMONSTRATED WHAT APPEARED TO BE A FRACTURED 2.6 F DUAL LUMEN PICC IN SITU AT THE LEVEL OF THE LT BRACHIOCEPHALIC VEIN.

  Patient problems: Insufficient Information

  MAUDE report 13394699 ↗
• MalfunctionNov 19, 2021Break; Break

  A PICC LINE BROKE AT THE HUB WHEN MOVING A PATIENT FROM THEIR CHAIR TO A BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846662 ↗
• MalfunctionMar 11, 2020Fracture; Fracture

  DURING BASIC CARE IT WAS NOTED THAT THE LUMEN WAS CRACKED BETWEEN THE 0 AND 2 CM MARK. CATHETER WAS SCHEDULED TO BE REMOVED LATER THAT DAY BUT WAS REMOVED 4 HOURS EARLIER THAN PLANNED WITH NO INFLUENCE TO THE CONDITION OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9817310 ↗
• MalfunctionFeb 3, 2020Leak/Splash; Leak/Splash

  THE BANDAGE WAS NOTED TO BE SOAKED. THE BANDAGE WAS CHANGED AND NO LEAK WAS DETECTED AT THAT TIME. A SHORT TIME LATER THE BANDAGE WAS SOAKED AGAIN AND THE PATIENT'S ARM WAS SWOLLEN. THE PATIENT'S HEART RATE HAD NOT DROPPED DESPITE THE INCREASE IN HEART RATE DECREASING MEDICATION. IT WAS THEN CLEARLY VISIBLE THAT THE INFUSION FLUID WAS RUNNING OUT NEXT TO THE PUNCTURE SITE.

  Patient problems: Extravasation; Swelling

  MAUDE report 9660570 ↗
• MalfunctionDec 9, 2019Disconnection; Disconnection

  IL RN PAGED TO ROOM, UPON ARRIVAL FOUND PICC DISCONNECTED @ IL CATHETER + PICC DRSG IN PLACE, IL S/A BLOOD. DRSG D/C'D + PRESSURE APPLIED @ INSERTION SITE + CALLED FOR ASSISTANCE.

  Patient problems: Blood Loss

  MAUDE report 9438349 ↗
• MalfunctionDec 9, 2019Leak/Splash; Leak/Splash

  THE WHITE LUMEN OF THE PICC LINE IS LEAKING. MICROCLAVE WAS CHANGED BUT STILL LEAKING. IV FUSION STOPPED FROM THAT LUMEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9437856 ↗
• MalfunctionJul 2, 2018Leak/Splash; Leak/Splash

  PICC WAS PLACED ON (B)(6) 2018. ON (B)(6) WAS UP THE NECK. DOCTOR ORDERED THE PICC TO BE PULLED BACK 3 CM. ONCE PICC WAS PULLED BACK NOTICED LEAKING AROUND 6 CM MARK. PICC TAKEN OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7656119 ↗
• MalfunctionApr 18, 2018Leak/Splash; Leak/Splash

  "RN CALLED TO INFORM PICC LINE LEAKING, WENT TO EXAMINE, DRESSING SATURATED WHEN FLUSHED. PICC LINE LEAKING AT WHITE HUB AREA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7439974 ↗