PowerPICC SOLO CK000524ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741124068), received between Dec 21, 2018 and Mar 25, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 18, 2026.

Recalls naming this device

1. Mar 11, 2025Class IOpen, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER WAS NOT STRONG AND MUSHROOMED BACK/BENT CAUSING A NEED TO NICK SKIN OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880005 ↗
• InjuryDec 21, 2018Failure to Advance

  IT WAS REPORTED THAT A DUAL LUMEN POWERPICC SOLO INSERTION WAS ATTEMPTED ON (B)(6) 2018, UNSUCCESSFUL W/ MULTIPLE ATTEMPTS. IT WAS STATED THAT RN WAS ABLE TO CANNULATE BUT WAS NOT PLACED IN SVC- ABORTED. THEN A SECOND CLINICIAN ATTEMPTED WITH A SINGLE LUMEN, AND UNSUCCESSFUL. THE PATIENT CAME BACK TO THE HOSPITAL (MONDAY (B)(6) 2018) WITH COMPLAINTS OF SWELLING AND PAIN IN RIGHT ARM. THEN PATIENT WAS ADMITTED AFTER ASSESSMENTS AND TESTS IT WAS NOTED A 2.6 CM SEGMENT OF WIRE IN RIGHT SUBCLAVIAN VEIN. THIS REPORT ADDRESSES THE SECOND CATHETER. ADDITIONAL INFORMATION RECEIVED STATED, "WE WERE UNABLE TO ADVANCE THE CATHETER PAST THE LEVEL OF THE RIGHT SUBCLAVIAN. RESISTANCE TO THE CATHETER WAS NOTED BY BOTH PRACTITIONERS AT THE SAME POINT (THE LEVEL OF THE RIGHT SUBCLAVIAN). NO ATTEMPTS WERE MADE TO ADVANCE THE CATHETER OR THE WIRE BEYOND THAT. CONTRALATERAL ATTEMPT NOT POSSIBLE DUE TO RADICAL MASTECTOMY WITH LYMPH NODE RESECTION."

  Patient problems: Foreign Body In Patient; Pain; Swelling

  MAUDE report 8189573 ↗