PowerPICC SOLO2 Catheter 3396355Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741028502), received between Mar 30, 2017 and Apr 30, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LEAKING AT SITE WHEN WHITE LUMEN FLUSHED. WHEN REMOVED, DEFINITE SLIT IN PICC FROM 3-4.5 CM MARK. PICC INSERTED (B)(6) 2021 AND STARTED LEAKING (B)(6) 2021" ADD INFO RCVD (B)(6) 2021: EXPLANT DATE: (B)(6) 2021. PLACEMENT INFO: RIGHT UPPER ARM WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: 5FR SECURACATH. WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752567 ↗
• MalfunctionJan 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CLINICIAN FOUND THE DEVICE SHEATHS TO BE DIFFICULT AND TRAUMATIC TO INSERT. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THERE WAS DIFFICULT INSERTION WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547458 ↗
• InjuryJan 3, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CLINICIAN FOUND THE DEVICE SHEATH TO BE DIFFICULT AND TRAUMATIC TO INSERT. IT IS FURTHER REPORTED THAT THIS RESULTED IN A DVT.

  Patient problems: Thrombus

  MAUDE report 9547437 ↗
• MalfunctionJan 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CLINICIAN FOUND THE DEVICE SHEATHS TO BE DIFFICULT AND TRAUMATIC TO INSERT. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THERE WAS DIFFICULT INSERTION WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547384 ↗
• InjuryJan 3, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CLINICIAN FOUND THE DEVICE SHEATH TO BE DIFFICULT AND TRAUMATIC TO INSERT. IT IS FURTHER REPORTED THAT THIS RESULTED IN A DVT.

  Patient problems: Thrombus

  MAUDE report 9547326 ↗
• MalfunctionMar 30, 2017Crack

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY STATED THE HUB CRACKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446587 ↗