VASCU-PICCRecalls & reported problems across all models

We found 22 models of VASCU-PICC by Medical Components, Inc. in the FDA's device registry (GUDID). Together they are named in 129 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2017 and Sep 24, 2026 — classified as 1 death, 13 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (77 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VASCU-PICC problems

VASCU-PICC models

22 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vascu-PICC® MR17012601

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  25 reports
• VASCU-PICC® MD17012601

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  23 reports
• Vascu-PICC® MR170126024S

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  13 reports
• Vascu-PICC® MR17012600

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 death11 reports
• VASCU-PICC® MD170126024S

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  11 reports
• VASCU-PICC® MRVSP26001

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  8 reports
• VASCU-PICC® MD17012600

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  6 reports
• VASCU-PICC® MD17012601

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  5 reports
• Vascu-PICC® MR17011101

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  4 reports
• VASCU-PICC® MR17022601

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  4 reports
• VASCU-PICC® MD17012600

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  4 reports
• VASCU-PICC® MD17022601

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  3 reports
• VASCU-PICC® MRVSP26001

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 reports
• VASCU-PICC® MD170126024S

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  2 reports
• Vascu-PICC® MR17014201

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Vascu-PICC® MR17015205

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• VASCU-PICC® MR17012608

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• Vascu-PICC® MR170126224S

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report
• VASCU-PICC® MD17011100

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report
• VASCU-PICC® MD170111024S

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report
• VASCU-PICC® MD17011100

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report
• VASCU-PICC® MD17022601

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report

Recent VASCU-PICC adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjurySep 24, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  Device leaking.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883029 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 26, 2026Leak/Splash

  THE NURSE WAS PLACING A PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE IN PATIENT AS ORDERED. THE PATIENT WAS PREPPED AND A 3 FRENCH 5CM INTRODUCER/DILATOR WAS INSERTED WITHOUT ISSUE. A 2.6 FRENCH DOUBLE LUMEN PICC WAS THEN OPENED AND ADVANCED THROUGH THE INTRODUCER WITHOUT RESISTANCE. WHILE FLUSHING THE PICC TO CHECK FOR PATENCY, THE RED LUMEN WAS NOTED TO BE LEAKING AT THE INSERTION SITE. THE WHITE LUMEN REMAINED INTACT. A DEFECT OF THE PICC LINE WAS IDENTIFIED AND THE LINE WAS REMOVED AND REPLACED WITH ANOTHER 2.6 FRENCH DOUBLE LUMEN PICC OF THE SAME LOT NUMBER. NO LEAKING WAS NOTED IN EITHER LUMEN OF THE SECOND PICC LINE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278941 ↗
• 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 ↗
• MalfunctionApr 27, 2026Leak/Splash

  FLUSHING BOTH SIDES RESULTED IN A LUMEN LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997819 ↗
• MalfunctionMar 6, 2026Leak/Splash

  PATIENT PICC LINE FOUND TO HAVE A RUPTURED PORTION OF THE LINE AT THE 5CM MARK AND INFILTRATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536492 ↗
• MalfunctionMar 4, 2026Leak/Splash

  INSERTING PICC AND NOTICED FLUID COMING OUT OF THE CATHETER AROUND THE 3 CM MARK. IT APPEARS THERE IS A SMALL HOLE IN THE CATHETER. PICC WAS REMOVED AT THE TIME OF INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508157 ↗
• 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 ↗
• MalfunctionFeb 4, 2026Leak/Splash

  PATIENT'S PICC LINE FOUND TO HAVE CRACK WHEN LINE AND HUB MET AS MEDICATION FOUND TO BE COMING FROM PICC LINE NEAR INSERTION SITE UNDERNEATH OCCLUSIVE DRESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257106 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 1, 2025Flushing Problem; Leak/Splash; Flushing Problem; Leak/Splash

  RN'S HAVE EXPERIENCED DIFFICULTY IN THE PAST 24 HOURS WITH FLUSHING AND WITHDRAWING BLOOD FROM THE RED LUMEN OF PATIENT'S 2.6F PICC CATHETER. PATIENT NOW COMPLAINING OF PAIN AT INSERTION SITE WHEN ATTEMPTS AT FLUSHING THE RED LUMEN OCCUR. BEDSIDE RN NOTIFIED ATTENDING MD AND RED LUMEN TO NO LONGER BE USED AT THIS TIME. IVT CONSULTED. IR CONSULT PLACE AND PLAN FOR PATIENT TO GET LINE RE-WIRED/REPLACED.

  Patient problems: Pain

  MAUDE report 23683928 ↗

Other Medical Components, Inc. products

• DIGNITY10 models · 12 reports · 1 recall
• Dignity Mid-Sized CT Port4 models · 4 reports · 1 recall
• Dignity Low Profile CT Port4 models · 4 reports · 1 recall
• Hemo-Cath10 models · 42 reports
• SLX Hemo-Cath4 models · 32 reports
• Pro-PICC CT12 models · 31 reports
• Split Cath III14 models · 26 reports