PowerPICC SOLO 1194108D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741154782), received between Feb 2, 2023 and Jun 26, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Defective Component” (6 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Mar 11, 2025Open, 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 · 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.

• MalfunctionJun 26, 2026Fluid/Blood Leak

  IT WAS REPORTED PATIENT RETURNED TO HAVE PICC REPLACED DUE TO DIFFICULTY FLUSHING AND BEING "POSITIONAL" FOR USE. ONCE PICC WAS REMOVED WAS FOUND TO HAVE A FRACTURE AT 7 CM. THE COURSE OF TREATMENT WAS NOT ALTERED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636233 ↗
• MalfunctionJul 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PATIENT RECEIVED LEFT BRACHIAL SINGLE LUMEN PICC PLACEMENT AND WAS GETTING AT HOME TPN. DUE TO WAKING UP WITH TPN HAVING LEAKED OUT AND BED SIGNIFICANTLY WET. PATIENT ALSO NOTED NO BLOOD RETURN FOR A COUPLE OF DAYS PRIOR. PATIENT COMPLAINED OF PAIN WHEN FLUSHING IN UPPER ARM. PICC LINE WAS REMOVED IN EMERGENCY DEPARTMENT BY VAT RN AND ON INSPECTION NOTED A HOLE AT THE 8CM MARK OF THE CATHETER. LINE WAS REPLACED AND PATIENT DISCHARGED.

  Patient problems: Infiltration into Tissue; Pain

  MAUDE report 22630303 ↗
• MalfunctionMay 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC LINES WERE DEFECTIVE AND LEAKING. ADDITIONAL INFORMATION: THE PICC WAS REMOVED AND REPLACED 3/14/25. THE PICC WAS DISCARDED AFTER PHOTOS WERE TAKEN. THE PATIENT WAS ALREADY BEING ADMITTED FOR SURGERY AND THE PICC WAS ABLE TO BE REPLACED DURING THAT ADMISSION SO THERE DID NOT END UP BEING A DELAY IN TREATMENT THAT I AM AWARE OF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006772 ↗
• MalfunctionNov 20, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT GREEN SAFETY COVER CAME OFF OF THE INNER SAFETY COMPONENT ON PICC KIT SAFETY INTRODUCER NEEDLE. AS A RESULT, THE NEEDLE BEVEL COULD NOT BE COVERED. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 22, 2024: NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733922 ↗
• MalfunctionFeb 15, 2023Defective Component; Defective Component

  IT WAS REPORTED BY BD SALES REPRESENTATIVE ¿DURING CLINICAL VISIT, STAFF REPORTED THAT AIR IS BEING INTRODUCED INTO THE WIRE CONNECTOR ADAPTER OF THE PICC LINE. A 4 FRENCH SINGLE LUMEN PICC KIT WAS OPENED FOR DEMONSTRATION. THE LINE WAS PRIMED WITH SALINE AND AIR IS ENTERING EITHER FROM THE HOLE THE WIRE PASSES THROUGH OR AT THE CONNECTION TO THE PLASTIC (THE RUBBERIZED PIECE THE WIRE STYLET PASSES THROUGH).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383547 ↗
• MalfunctionFeb 14, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER ¿ONE OF OUR PICC NURSES NOTED AIR BEING INTRODUCED INTO THE WIRE CONNECTOR ADAPTER OF THE LINE UPON ASPIRATION DURING ASSESSMENT OF BLOOD RETURN ON THREE SINGLE LUMEN 4 FRENCH PICCS.¿ THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372088 ↗
• MalfunctionFeb 14, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER ¿ONE OF OUR PICC NURSES NOTED AIR BEING INTRODUCED INTO THE WIRE CONNECTOR ADAPTER OF THE LINE UPON ASPIRATION DURING ASSESSMENT OF BLOOD RETURN ON THREE SINGLE LUMEN 4 FRENCH PICCS.¿ THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372085 ↗
• MalfunctionFeb 14, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER ¿ONE OF OUR PICC NURSES NOTED AIR BEING INTRODUCED INTO THE WIRE CONNECTOR ADAPTER OF THE LINE UPON ASPIRATION DURING ASSESSMENT OF BLOOD RETURN ON THREE SINGLE LUMEN 4 FRENCH PICCS.¿ THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372072 ↗
• MalfunctionFeb 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THE YELLOW RUBBER SEAL ON THE T-CONNECTOR SET IS NOT MAKING A COMPLETE SEAL. AIR AND SALINE LEAK WHEN FLUSHING AFTER THE LINE HAS ALREADY BEEN PRIMED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED. NO PATIENTS HAVE BEEN HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359656 ↗
• MalfunctionFeb 2, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "YELLOW RUBBER SEAL ON T-CONNECTOR SET NOT MAKING COMPLETE SEAL, AIR AND SALINE LEAKAGE WHEN FLUSHING AFTER LINE HAS ALREADY BEEN PRIMED, USER HAS CONCERN ABOUT AIR ENTERING THE LINE." ADD INFO RCVD 01/18/2023: REGARDING THE DESCRIPTION, ESSENTIALLY ONE OF OUR PICC NURSES NOTED AIR BEING INTRODUCED INTO THE WIRE CONNECTOR ADAPTER OF THE LINE UPON ASPIRATION DURING ASSESSMENT OF BLOOD RETURN WITH THE LATEST BATCH OF SINGLE LUMEN 4 FRENCH PICCS. WE HAD DISCUSSED THIS AND OPENED ANOTHER KIT OF THE SAME LOT, PRIMED A LINE WITH SALINE AND TOOK A VIDEO TO ATTEMPT TO DETERMINE WHAT WAS HAPPENING. IT APPEARS EITHER THE CONNECTION OF THE RUBBERIZED PIECE THE WIRE STYLET PASSES THROUGH IS THE ISSUE, WITH AIR ENTERING FROM EITHER THE HOLE THE WIRE PASSES THROUGH OR AT THE CONNECTION TO THE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16288027 ↗