PowerPICC SOLO2 HF Catheter 1395118QRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741085727), received between Feb 10, 2017 and Jun 24, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.

• 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 ↗
• InjuryMay 21, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THERE ARE STYLET ISSUES. ADDITIONAL INFORMATION RECEIVED 5/5/2021: IT WAS REPORTED ON (B)(6) THAT THE STYLET WAS BROKEN. THE BROKEN PIECE REMAINS IN THE PATIENT'S AXILLA AND HAS BEEN DETERMINED TO BE IRRETRIEVABLE. IT WAS STATED THAT THE PICC FELT RESISTANCE WHEN THREADING AND THAT THE INSERTION HAD TO BE ABORTED. THE STYLET WIRE WAS CHECKED AND IT WAS NOTED THAT 1CM OF THE STYLET TIP WAS MISSING AND WAS UNABLE TO BE FOUND IN THE STERILE FIELD. AN X-RAY WAS PERFORMED AND THE MISSING PIECE WAS FOUND IN THE PATIENT'S HEMITHORAX.

  Patient problems: Foreign Body In Patient

  MAUDE report 11866698 ↗
• MalfunctionMay 5, 2021Material Frayed; Material Frayed

  IT WAS REPORTED PICC NURSE INSERTED PICC IN PT. AND WHEN STYLET WAS REMOVED FROM PICC IT WAS NOTED THAT STYLET TIP WAS BENT AND ALMOST BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780483 ↗
• MalfunctionJan 2, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC IS KINKING ON ITSELF UNDER THE EXISTING DRESSING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539032 ↗
• MalfunctionFeb 10, 2017Kinked

  NURSE REPORTED A KINK ON THE EXTERNAL PORTION OF THE PICC. THE PICC LINE WAS INSERTED ON (B)(6) 2017. THE RIGHT CEPHALIC VEIN WAS USED, AS THE BASILICA VESSEL WAS BEING USED FOR IV MEDICATION. THE PICC LINE WAS TRIMMED AT 50 CM AND HAD AN EXTERNAL LENGTH OF 1.5 CM. CHEST X-RAY WAS COMPLETED POST INSERTION AS THE PATIENT WAS IN ATRIAL FIBRILLATION. PICC REMAINS IN THE PATIENT AND HAS BEEN SECURED. NO PATIENT INJURY REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 6321889 ↗
• MalfunctionFeb 10, 2017Kinked

  NURSE REPORTED A KINK ON THE EXTERNAL PORTION OF A PICC. THE PICC LINE WAS INSERTED ON (B)(6) 2017. THE RIGHT BASILIC VEIN WAS USED. THE PICC LINE WAS TRIMMED AT 50 CM AND HAD AN EXTERNAL LENGTH OF 3 CM. NO COMPLICATIONS DURING THE INSERTION AND NO MANIPULATION OF THE PICC WAS REQUIRED. THE PICC WAS INSERTED USING 3CG TECHNOLOGY AND NO CHEST X-RAY WAS DONE. THE PICC CURRENTLY REMAINS IN THE PATIENT AND HAS BEEN SECURED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6321795 ↗