PowerPICC SOLO CK000931Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741188107), received between Dec 18, 2019 and Dec 16, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED "PICC PLACED WITH NO RESISTANCE OR ISSUES, PICC PLACER. ONCE PICC WAS PLACED IN PROPER CAJ THE STYLET WAS REMOVED. IT WAS NOTED THE THAT END OF THE STYLET WAS BENT AND LOOKED LIKE IT WAS GOING TO FALL OFF. PLACER PLACED THE STYLET ON THE TRAY AND THE END OF THE STYLET FELL OFF. THE PICC TEAM VERBALIZED CONCERN FOR STYLET BREAKING OFF IN PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018720 ↗
• MalfunctionFeb 5, 2021Material Twisted/Bent

  IT WAS REPORTED THE MICROINTRODUCER FEELS FLIMSY AND BENDS. NO OTHER INFORMATION WAS PROVIDED. 01/13/2021-IT WAS FOUND THAT THE INTRODUCER SHEATH TIP WAS BUCKLED AND FLARED SLIGHTLY OUTWARD ON THE RETURNED SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11289313 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE EIGHTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492029 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE THIRD KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492024 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE FIFTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492023 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE SEVENTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492022 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE SIXTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492018 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE FOURTH KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492006 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE SECOND KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492002 ↗
• 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 9491991 ↗
• 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 IT WAS NOTED WITH EIGHT KITS. THIS REPORT ADDRESSES THE FIRST KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491984 ↗