PowerPICC SOLO CK000590ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741137631), received between Sep 4, 2019 and Apr 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE CLINICIAN WAS PREPARING PICC, DREW BACK GUIDEWIRE TO TRIM AND NOTICED A RED STRING/ THREAD ATTACHED WITH THE GUIDEWIRE FROM INSIDE THE PICC. (FOREIGN OBJECT). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790661 ↗
• MalfunctionMar 24, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER VIA PHONE, THAT THERE WAS A NOTICEABLE RED FOREIGN MATTER LOCATED INSIDE THE POWERPICC DEVICE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16611522 ↗
• MalfunctionSep 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem; Data Problem; Data Problem

  IT WAS REPORTED THAT THE RN TRIMMED THE PICC AT 40CM AND WHEN PLACING THE PICC SHE SAW THE SHERLOCK STYLET ICON GO DOWNWARD BUT NEVER SAW AND CHANGES WITH THE P-WAVE. IT WAS STATED THE RN ATTEMPTED SOME TROUBLESHOOTING BUT SAW NO CHANGES IN THE P-WAVE. RN SAID SHE SECOND GUESSED HER MEASUREMENTS SO CALLED FOR ANOTHER PICC KIT. THE RN LEFT SOME ADDITIONAL LENGTH ON THE NEW PICC USED AND WHILE PLACING THE PICC "IMMEDIATELY SAW CHANGES IN THE P-WAVE AS SHE ADVANCED THE CATHETER". THE SECOND PICC WAS PLACED SUCCESSFULLY. ANOTHER RN STATED SHE TOO HAD "A SIMILAR EXPERIENCE RECENTLY" WITH THE SAME LOT. THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8961292 ↗
• MalfunctionSep 4, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RN TRIMMED THE PICC AT 40 CM AND WHEN PLACING THE PICC SHE SAW THE SHERLOCK STYLET ICON GO DOWNWARD BUT NEVER SAW AND CHANGES WITH THE P-WAVE. IT WAS STATED THE RN ATTEMPTED SOME TROUBLESHOOTING BUT SAW NO CHANGES IN THE P-WAVE. RN SAID SHE SECOND GUESSED HER MEASUREMENTS SO CALLED FOR ANOTHER PICC KIT. THE RN LEFT SOME ADDITIONAL LENGTH ON THE NEW PICC USED AND WHILE PLACING THE PICC "IMMEDIATELY SAW CHANGES IN THE P-WAVE AS SHE ADVANCED THE CATHETER." THE SECOND PICC WAS PLACED SUCCESSFULLY. ANOTHER RN STATED SHE TOO HAD "A SIMILAR EXPERIENCE RECENTLY" WITH THE SAME LOT. THIS REPORT ADDRESSES THE SECOND EVENT THAT WAS "SIMILAR" TO THE FIRST WITH NO FURTHER DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961291 ↗