PowerPICC Provena SOLO S1295108FD4Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741155116), received between Jul 23, 2019 and Jul 31, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN OPENING KIT TO PLACE PICC, THERE WAS A HAIR FOUND ON TOP OF THE ENCLOSED STERILE GOWN. UPON FURTHER INSPECTION, THERE WERE NO OTHER HAIRS FOUND ANYWHERE WITHIN THE KIT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682553 ↗
• InjuryApr 28, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT RN WAS INSERTING PICC LINE AND PACKING MATERIAL MALFUNCTIONED. AFTER FLUSHING THE LINE, THE RUBBER STOPPER IN THE TUBING FLIPPED CAUSING BACKFLOW OF BLOOD TO SPLASH IN RN'S FACE. NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21918546 ↗
• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC WAS PULLED OUT OF PATIENT AND HAD A HOLE IN THE CATHETER NEAR THE 0CM MARK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621234 ↗
• MalfunctionFeb 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PICC LINE HAS BEEN PLACED AND CONFIRMED WITH A 3CG DEVICE. HOWEVER, THE X-RAYS AND READINGS STATE THAT THE PICC LINES WERE TOO DEEP IN THE PATIENT'S ANATOMY. NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461204 ↗
• MalfunctionNov 14, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT WHEN STYLET WITHDRAWN TO TRIM CATHETER, WHEN THE STYLET WAS RE-ADVANCE THROUGH THE CATHETER AND WAS VISUALIZED IT WAS NOTED TO HAVE TWO SIGNIFICANT KINKS. WHEN TOUCHED TO INSPECT THE KINK THE TIP OF THE STYLET BROKE OFF. THE WHOLE PICC KIT WAS REPLACED, SO THIS CATHETER DID NOT TOUCH THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18137003 ↗
• MalfunctionSep 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT BEFORE PROCEDURE KINKS WERE INSPECTED IN THE LOWER 1/3RD OF THE WIRE. PICC WAS NOT USED DURING PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695378 ↗
• MalfunctionMay 26, 2023Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  CUSTOMER REPORTED THAT DURING PICC PLACEMENT THE USER EXPERIENCED DIFFICULT BREAKING THE INTRODUCER SHEATH WHEN FINALIZING THE PLACEMENT OF A PICC. THE INTRODUCER DID NOT CRACK CLEANLY, AND THE TEAM ALMOST HAD TO COMPLETELY RESTART BUT THEY WERE ABLE TO BREAK AWAY ENOUGH OF THE INTRODUCER TO SAFELY REMOVE IT AND FINALIZE PICC PLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010678 ↗
• MalfunctionMay 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "ISSUE WITH TWO PICCS THAT WERE INSERTED BY TWO DIFFERENT NURSES. BOTH HAD TROUBLE WITH THE INTRODUCER NOT HAVING A CLEAN SPLIT OF THE RED PART INSIDE THE INTRODUCER. THERE WERE PIECES OF THE RED INNER CORE FRAYED AND THE PICC WAS THEN STUCK IN THE INTRODUCER. THE NURSES HAD TO CUT AWAY THE RED PLASTIC INNER PART." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896891 ↗
• MalfunctionMay 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "ISSUE WITH TWO PICCS THAT WERE INSERTED BY TWO DIFFERENT NURSES. BOTH HAD TROUBLE WITH THE INTRODUCER NOT HAVING A CLEAN SPLIT OF THE RED PART INSIDE THE INTRODUCER. THERE WERE PIECES OF THE RED INNER CORE FRAYED AND THE PICC WAS THEN STUCK IN THE INTRODUCER. THE NURSES HAD TO CUT AWAY THE RED PLASTIC INNER PART." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896859 ↗
• MalfunctionJul 23, 2019Unraveled Material

  IT WAS REPORTED THAT WHILE INSERTING THE PICC THE GUIDEWIRE UNRAVELED AT THE TIP. THEY WERE ABLE TO REMOVE THE ENTIRE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8818895 ↗