PowerPICC SOLO CK000525ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741124075), received between Sep 20, 2018 and Mar 26, 2021 — classified as 1 injury, 4 malfunctions.

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

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A GUIDE WIRE FRAYED. ADDITIONAL INFORMATION RECEIVED 3/17/2021: IT WAS REPORTED THE TIP OF THE GUIDE WIRE WAS FRAYED UPON REMOVAL DURING A PICC LINE INSERTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576702 ↗
• 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 9879885 ↗
• MalfunctionJul 31, 2019Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT THE PICC LINE KNOTTED AND DIFFICULT TO REMOVE. REMOVED WITHOUT ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848313 ↗
• 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 FIRST 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 8189527 ↗
• MalfunctionSep 20, 2018Problem with Sterilization; Material Split, Cut or Torn

  IT WAS REPORTED POWERPICC SOLO WAS TORN AT BASE OF CATHETER OUT OF STERILE PACKAGE. IT WAS NOT USED ON PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7896182 ↗