PowerPICC SOLO2 HF Catheter 1395108QRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741034718), received between Sep 9, 2016 and Sep 9, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2016Material Fragmentation; Difficult to Insert; Physical Resistance

  ON (B)(6) 2016 - FACILITY REPORTED THAT WHILE NURSE WAS PLACING A POWERPICC SOLO WITH THE SHERLOCK ULTRASOUND DEVICE, SHE MET RESISTANCE. NURSE REQUESTED ASSISTANCE FROM ANOTHER NURSE, STILL MET RESISTANCE AND CALLED FOR THE RADIOLOGIST. DEVICE WAS REMOVED UNDER CT SCAN. HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PIECE OF THE WIRE BROKE OFF AND REMAINED IN THE PATIENT. RADIOLOGIST WAS UNABLE TO RETRIEVE THE BROKEN PIECE OF WIRE. HCP ALLEGED THAT THE WIRE MAY HAVE UNRAVELED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5939755 ↗