PowerPICC SOLO CK000930Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741188091), received between Dec 18, 2019 and Jul 1, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Break; Break

  IT WAS REPORTED VASCULAR ACCESS NURSE STATED SHE RAN INTO A PATIENT TODAY THAT SHE PLACED A PICC IN ON (B)(6) PICC WAS TRIMMED TO 41CM. PATIENT TOLD HER WHEN HOME HEALTH NURSE REMOVED THE LINE, SHE THOUGHT IT LOOKED SHORT SO SHE SAVED REMOVED PICC. PATIENT THEN WENT TO ER AND THEN ENDED UP HAVING 20CM REMOVED FROM HER VIA IR. THEY ALSO EMAILED THIS DESCRIPTION RETAINED PICC AFTER PICC REMOVAL. IT IS UNKNOWN IF IR KEPT FRAGMENT, PATIENT REPORTS HAVING PORTION THAT THE HOME HEALTH NURSE REMOVED AT HOME. REGARDING HER COMPLICATION, SHE REQUIRED AN INVASIVE PROCEDURE AND ADDITIONAL MEDICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22371077 ↗
• MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY BD SALES REP "I HAD A CUSTOMER REPORT THAT THEY HAD A PICC THAT WAS REMOVED AND NEEDED REPLACED DUE TO A LEAK IN THE CLEAR STEM BETWEEN THE NEEDLESS CONNECTOR AND PICC HUB. THE PICC WAS PLACED AT ANOTHER FACILITY AND WAS PLACED ON (B)(6)." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753383 ↗
• MalfunctionMar 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT OUTPATIENT PICC CAME BACK INTO HOSPITAL DUE TO LEAKING. THEY DID NOT SEE A LEAK UNTIL THEY REMOVED THE PICC LINE AND SAY A HOLE IN THE PICC ABOUT 5CM DOWN. ADDITIONAL INFORMATION RECEIVED 02/26/2024: PATIENT HAD PICC PLACED (B)(6) 2024 WAS DISCHARGED HOME. HE RETURNED TO THE HOSPITAL (B)(6) 2024 EVENING DUE TO PICC LEAKING. ON (B)(6) 2024, WENT TO EVALUATE PATIENTS PICC (B)(6), REMOVED PICC AND THERE WAS A LEAK. PLACED NEW PICC (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908760 ↗
• MalfunctionDec 19, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE VALVE WOULDN'T WORK UNLESS THEY PUT THE WIRE BACK INTO THE VALVE. 12/6/2019- ADDITIONAL INFORMATION FROM FACILITY STATED, "PLACED IN LEFT BASILIC VEIN, ONE ATTEMPT, EASILY INSERTED. PICC WAS TESTED PRIOR TO INSERTION WITH TRAY SET UP ABLE TO FLUSH AND ASPIRATE PRIOR TO INSERTION. PLACED PICC EASILY ON ONE ATTEMPT, EASILY INSERTED, FLUSHED EASILY, SHERLOCK TRACKED IT INTO THE SVC AND CONFIRMED CORRECT PLACEMENT PER ECG, (BLOOD DID COME BACK AS NOTE IN THE EXTERNAL PART OF PICC, AND AFTER PICC IN PLACE AND GUIDEWIRE REMOVED, FLUSHED EASILY BUT UNABLE TO ASPIRATE, PULLED OUT TO 10 CM, STILL NOT ABLE TO ASPIRATE, CHANGED CAPS, FLUSHED TOTAL OF 10 ML X 10 DIFFERENT POSITIONING OF PATIENT, TO NO AVAIL, UNABLE TO ASPIRATE BACK ANY BLOOD, REINSERTED GUIDEWIRE THROUGH THE EXTERNAL VALVE AND WENT ONLY IN ABOUT 6 CM AND BLOOD CAME BACK WHILE GUIDE WIRE WAS STILL IN. BUT ONCE WIRE WAS REMOVED, AGAIN TO NO AVAIL , PICC WOULD NOT ASPIRATE BACK. REPEATED THIS AGAIN, ONLY ABLE TO ASPIRATE WHEN I PUT GUIDEWIRE BACK INTO THE PICC AND ONCE PAST THE EXTERNAL VALVE BLOOD CAME BACK. THE GUIDEWIRE WAS REMOVED AND THEN UNABLE TO ASPIRATE BLOOD BACK. PICC REMOVE, HAD TO RESTICK PAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496929 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. IT WAS REPORTED THIS WAS NOTED WITH SEVEN KITS. THIS FILE ADDRESSES THE FOURTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492093 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. IT WAS REPORTED THIS WAS NOTED WITH SEVEN KITS. THIS FILE ADDRESSES THE SIXTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492017 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. IT WAS REPORTED THIS WAS NOTED WITH SEVEN KITS. THIS FILE ADDRESSES THE SEVENTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492016 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. IT WAS REPORTED THIS WAS NOTED WITH SEVEN KITS. THIS FILE ADDRESSES THE SECOND KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492001 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. IT WAS REPORTED THIS WAS NOTED WITH SEVEN KITS. THIS FILE ADDRESSES THE FIFTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492000 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. IT WAS REPORTED THIS WAS NOTED WITH SEVEN KITS. THIS FILE ADDRESSES THE THIRD KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491999 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. IT WAS REPORTED THIS WAS NOTED WITH SEVEN KITS. THIS FILE ADDRESSES THE FIRST KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491992 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER IN THE KIT WAS DIFFICULT TO INSERT DUE TO THE TRANSITION BETWEEN THE INTRODUCER AND THE DILATOR NOT BEING SMOOTH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491988 ↗