PowerPICC SOLO2 Catheter 3194155Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741027765), received between Feb 24, 2016 and May 23, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT'S HOME HEALTH NURSE WAS NOT ABLE TO FLUSH THE DEVICE. PATIENT WAS SENT TO THE FACILITY. FACILITY CLINICIAN WAS ABLE TO FLUSH THE DEVICE WITH PULSATILE TECHNIQUE BUT HAS NOT BEEN ABLE TO ASPIRATE AND IS WONDERING IF IT COULD BE POSITIONAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080838 ↗
• MalfunctionApr 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT CAME FOR HER CHEMOTHERAPY TREATMENT. DURING THE TREATMENT, THE PATIENT VERBALIZED HAVING A BURNING SENSATION AT THE PICC SITE. WHEN THE PICC WAS REMOVED, IT WAS NOTED THAT THERE WAS A HOLE IN IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Burning Sensation; Infiltration into Tissue

  MAUDE report 21868600 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT HOLE IN THE PICC LINE AT THE 2CM MARK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164068 ↗
• InjuryMay 23, 2024Break; Break

  IT WAS REPORTED, "A BROKEN PICC IN A PATIENT. I AM THE SUPERVISOR AND WE HAD A PICC BREAK APART DURING REMOVAL. HALF WAS LEFT IN THE PATIENT. WE SNARED IT OUT AND HAVE BOTH PIECES." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 05/02/2024: IT WAS REPORTED, "S/L PICC LINE PLACED IN RT IJ. LOT# REHU2613. DATE OF EVENT WAS 04/29/24. NO PATIENT IMPACT."

  Patient problems: Foreign Body In Patient

  MAUDE report 19383899 ↗
• InjuryMay 15, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT THE GUIDE CRUMBLED AND DISINTEGRATED DURING INSTALLATION. THIS HAD SERIOUS CONSEQUENCES FOR A PATIENT WHO REQUIRED SURGERY TO REMOVE GUIDEWIRE FRAGMENTS STUCK IN HIS PERIPHERAL VENOUS SYSTEM. ADDITIONAL INFORMATION RECEIVED MAY 1 2024: A PIECE OF THE GUIDE WIRE BROKE OFF AT INSTALLATION WHEN THEY WERE TRYING TO RETRIEVE THE WIRE AND STAYED AT THE PATIENT¿S INSERTION SITE. THE INTENSIVIST WAS ABLE TO MAKE A SMALL INCISION AT THE INSERTION SITE AND RETRIEVE THE SMALL PIECE FROM THE PATIENT. THE PIECE DID NOT GO INTO THE PATIENT¿S BLOOD STREAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321619 ↗
• MalfunctionApr 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SHEATH/INTRODUCER HAS AN EXTRA "BEAD" OF PLASTIC AND PREVENTS IT TO BE ADVANCED INTO THE VESSEL. NO PATIENT INVOLVEMENT. 4/08/2021- THE PHOTO PROVIDED FOR EVALUATION SHOWED THE INTRODUCER SHEATH TIP TO BE DEFORMED AND BUNCHED INWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757254 ↗
• MalfunctionApr 2, 2021Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  IT WAS REPORTED THAT POWERPICC SOLO CATHETER DEVELOPED MECHANICAL OCCLUSIONS(KINKING) IN-SITU AFTER INSERTION. THE INSERTION WAS UNREMARKABLE WITH NO DIFFICULTIES, FLUSHED AND ASPIRATED WITHOUT RESISTANCE ON INSERTION BUT PATIENT DEVELOPED OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607516 ↗
• MalfunctionOct 16, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING AT HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690594 ↗
• MalfunctionAug 5, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE WIRE, NOT THE TIP, GOT CAUGHT INSIDE THE NEEDLE AND TORE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370939 ↗
• InjuryFeb 24, 2016Break; Material Fragmentation; Material Frayed; Failure to Advance

  IT WAS REPORTED THAT DURING THE INSTALLATION OF A PICC LINE, THE TERUMO GUIDEWIRE APPARENTLY BROKE OFF IN THE PATIENT'S ARM. THE REMAINING PIECE WAS A FEW MM LONG. THEY REPORTEDLY WERE UNABLE TO REMOVE THE LEFT OVER PIECE. CHECKING THE POSITION OF EC IN THE NEXT SCAN TO SEE WHETHER MIGRATION OCCURED. THE FACILITY REPORTS IT WAS NOT THE TERUMO GLIDEWIRE THAT FRAYED BUT THE GUIDEWIRE INCLUDED IN THE KIT. IT WAS DURING NEEDLE PUNCTURE, ON INTRODUCTION OF THE MANUFATURERS GUIDEWIRE, THAT IT BECAME STUCK IN THE AXILLARY REGION. BEING UNABLE TO ADVANCE THE GUIDEWIRE, "WE DECIDED TO TAKE IT BACK OUT AGAIN FROM THE PUNCTURE NEEDLE. IT WAS AT THIS POINT THAT IT FRAYED. A SMALL PIECE OF METAL FROM THE GUIDEWIRE REMAINED IN THE PATIENT. SUBSEQUENTLY, WE TOOK A TERUMO GLIDEWIRE FITTED WITH A SMOOTHER, CURVED TIP, AND WERE FINALLY SUCCESSFUL IN PUTTING IN OUR PICC-LINE". A SMALL PIECE OF THE GUIDEWIRE REMAINS IN THE PATIENT. CHEST X-RAY ON (B)(6) 2015 SHOWED THAT THERE HAD BEEN NO MIGRATION OF THIS FOREIGN BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5457465 ↗