PowerPICC SOLO2 HF CatheterRecalls & reported problems across all models

We found 5 models of PowerPICC SOLO2 HF Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2016 and Feb 12, 2026 — classified as 1 death, 19 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (26 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 PowerPICC SOLO2 HF Catheter problems

PowerPICC SOLO2 HF Catheter models

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

• PowerPICC SOLO2 HF Catheter 1395108QD

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  114 reports
• PowerPICC SOLO2 HF Catheter 1395118Q

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  8 reports
• PowerPICC SOLO2 HF Catheter 3395335Q

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 death6 reports
• PowerPICC SOLO2 HF Catheter 3395355Q

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  3 reports
• PowerPICC SOLO2 HF Catheter 1395108Q

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

Recent PowerPICC SOLO2 HF Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT TWO DAYS AFTER PICC PLACEMENT, LEAKAGE AND A CRACK WERE OBSERVED AT ONE OF THE LUMENS. IT WAS REPORTED THAT THE PICC HAD BEEN PLACED ON (B)(6) 2026 WITH NO ISSUES NOTED AT THE TIME OF INSERTION, AND THE LEAKAGE WAS REPORTED ON (B)(6) 2026 BY NURSING STAFF. THE VASCULAR ACCESS CLINICIAN ON SHIFT DID NOT ASSESS THE LINE PRIOR TO REMOVAL, AND THE DEVICE WAS NOT RETAINED AND NO PHOTOS WERE TAKEN. THE PATIENT REPORTED NO PAIN, ONLY LEAKAGE UNDER THE DRESSING, AND THE RN REMOVED THE LINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323854 ↗
• MalfunctionJan 6, 2026Contamination /Decontamination Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHITE SUBSTANCE FOUND ON PICC LUMEN THREADING BEFORE INSERTION INTO PATIENT. NO IMPACT TO PATIENT, DELAY IN PROCEDURE AND NEW KIT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974030 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC IS LEAKING/CHANGING COLOR AT THE HUB. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667871 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT TRIPLE LUMEN PICC LEAKING UNDER THE SECURACATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22446107 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC IS BREAKING AND NOTICING LEAKING AT THE INSERTION. NO IMPACT KNOWN TO THE PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396259 ↗
• MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC IS BREAKING AND NOTICING LEAKING AT THE INSERTION. NO IMPACT KNOWN TO THE PATIENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387163 ↗
• InjuryJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "ON (B)(6), I RECEIVED A CONSULT TO INSERT A PICC IN A CRITICAL PATIENT IN ER. SUCCESSFUL PROCEDURE, BUT WHEN COMPLETING MY FINAL FLUSHES OF THE LINE, I NOTICED NORMAL SALINE LEAKING FROM THE WHITE LUMEN AND BLOOD BACK FLOWING. UPON FURTHER INSPECTION, I DISCOVERED A SMALL CRACK IN THE LINE RIGHT AT THE HUB OF THE PICC. I IMMEDIATELY PULLED THE LINE AND PLACED A BANDAGE. PATIENT NEEDED TO GO TO ICU URGENTLY SO I FOLLOWED PATIENT THERE AND COMPLETED A SECOND SUCCESSFUL PICC ATTEMPT IN ICU USING A DIFFERENT LOT NUMBER." ADDITIONAL INFORMATION RECEIVED (B)(6) 2025: IT WAS REPORTED THE CUSTOMER "PATIENT HAD AN ADDITIONAL PERIPHERAL IV BUT IT WASN'T GREAT. IT WAS A SMALLER GAUGE AND LEAKING. SHE WAS ALSO RUNNING NOREPINEPHRINE (WHICH IS A POTENT VASOCONSTRICTOR) THAT NEEDS TO BE RUNS CENTRALLY EX) VIA A PICC LINE. NO, IT DID NOT CONTRIBUTE TO THE DECLINE IN PATIENT CONDITION. THE PICC LINE WOULD HAVE HELPED THE STAFF CARE FOR THE PATIENT EASIER BUT SHE WAS ALREADY DETERIORATING AND GOING OVER TO ICU. ICU DID HOWEVER REQUIRE THE PICC LINE AS BY THE TIME SHE GOT TRANSFERRED TO ICU HER IV LINE HAD WENT INTERSTITIAL AND THEY NEEDED TO URGENTLY INTUBATE HER, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319166 ↗
• MalfunctionJan 28, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER, HAIR FOUND IN STERILE PICC TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256962 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT CRACKED PICC DISCOVERED WHEN FLUSHING PRIOR TO INSERTION. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: DURING FOLLOW UP WITH THE CUSTOMER, THIS WAS AN INSERTER ERROR, ONE OF THE NEW NURSES CUT THE PICC AND THEN STATED THE PICC WAS FOUND CRACKED FROM THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20574537 ↗
• MalfunctionNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT GRAY LUMEN OF TRIPLE LUMEN PICC WAS LEAKING WHEN THE IV/TRANSFUSION NURSE WAS CALLED TO CHECK THE CATHETER. PICC WAS REMOVED AND THEN CONFIRMED THAT IT WAS THE GRAY LUMEN THAT WAS LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136410 ↗
• MalfunctionNov 13, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT AFTER IT WAS USED AND, IN THE TRAY, THE LAST 3CM OF THE PICC GUIDEWIRE WAS FOUND BROKEN OFF FROM THE REST OF THE WIRE. IT WAS DETERMINED THAT THE COMPLETE GUIDEWIRE WAS REMOVED, AND THE WIRE WAS THEN DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124892 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "CALLER STATES HE WAS IN THE HOSPITAL FOR ABOUT 17 DAYS WITH A POWERPICC SOLO. CALLER STATES THEY REMOVED THE PICC FIVE DAYS AGO BUT HE CAN STILL FEEL TINGLING IN TWO FINGERS AND A THUMB. RESPONSE: EXPLAINED THAT IT IS POSSIBLE THAT THE CLINICIAN HIT A NERVE DURING PICC PLACEMENT. THIS MAY RESOLVE ITSELF IN A FEW DAYS BUT IT NEEDS TO BE REPORTED TO PHYSICIAN AS SOON AS POSSIBLE. THE DOCTOR MAY WANT TO FOLLOW UP WITH TREATMENTS. RESPONSE: EXPLAINED THAT IT IS POSSIBLE THAT THE CLINICIAN HIT A NERVE DURING PICC PLACEMENT. THIS MAY RESOLVE ITSELF IN A FEW DAYS BUT IT NEEDS TO BE REPORTED TO PHYSICIAN AS SOON AS POSSIBLE. THE DOCTOR MAY WANT TO FOLLOW UP WITH TREATMENTS."

  Patient problems: Numbness

  MAUDE report 17509730 ↗
• MalfunctionJul 12, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED, TRIPLE LUMEN PICC LINE WAS PLACED TODAY AND WHEN REMOVING THE STYLE IT WAS CURLED. ADDITIONAL INFORMATION 5/22/2023: PATIENT WAS NOT COMPROMISED, AND NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313024 ↗
• MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT, 2 TRIPLE LUMEN PICC LINES WERE PLACED TODAY AND WHEN REMOVING THE STYLET IN BOTH THE LINES WE PLACED THE STYLET CURLED. ADDITIONAL INFORMATION PROVIDED 22 MAY 2023 IT WAS REPORTED BY THE CUSTOMER "PATIENTS WERE NOT COMPROMISED, AND NO INJURY OCCURRED." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083529 ↗
• MalfunctionJun 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT, 2 TRIPLE LUMEN PICC LINES WERE PLACED TODAY AND WHEN REMOVING THE STYLET IN BOTH THE LINES WE PLACED THE STYLET CURLED. ADDITIONAL INFORMATION PROVIDED 22 MAY 2023 IT WAS REPORTED BY THE CUSTOMER "PATIENTS WERE NOT COMPROMISED, AND NO INJURY OCCURRED." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083525 ↗

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