PowerPICC SOLO Catheter 3195355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741027819), received between Apr 29, 2016 and Apr 12, 2017 — classified as 1 death, 1 malfunction.

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

• MalfunctionApr 12, 2017Backflow

  NURSE FROM THE FACILITY REPORTED SHE HAS A PATIENT THAT HAS POWERPICC SOLO THAT WAS PLACED AT ANOTHER FACILITY IN (B)(6). THE NURSE STATED THAT THE POWERPICC SOLO WOULD FLUSH BUT THERE WAS BLOOD BACKING UP INTO THE CLEAR PORTION OF THE PICC. SHE INQUIRED ABOUT WHAT CAN BE DONE TO KEEP THE BLOOD FROM BACKING UP IN THE PICC. IT WAS STATED THAT CHEST X-RAY HAS YET TO BE PERFORMED. MS&S INFORMED THE POWERPICC SOLO VALVE IS LOCATED IN THE DISK NEXT TO PROXIMAL END OF THE PICC. MS&S DISCUSSED WITH THE NURSE THAT A CHEST X-RAY FOR TIP LOCATION MAY BE NEEDED AND INFORMED THAT A DYE STUDY MAY HELP DIAGNOSE A FIBRIN SHEATH. MS&S ADVISED THAT THE PHYSICIAN COULD BE CALLED TO ASK ABOUT CATHFLO/TPA USAGE AND INFORMED TO NOT HAVE THE CATHETER ABOVE THE HEART WHEN FLUSHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6487980 ↗
• DeathApr 29, 2016Insufficient Device Problem Information

  ON (B)(6) 2016 - IT WAS REPORTED BY COMPLAINANT (PATIENT¿S DAUGHTER), THAT WHEN THE POWER PICC WAS PLACED, THE PATIENT EXPERIENCED NUMBNESS IN HER LEFT ARM, AND TINGLING IN HER LEFT FINGERS. THE PATIENT WENT INTO CARDIAC ARREST AND PASSED AWAY. COMPLAINANT WAS ASKING IF THE POWER PICC COULD CAUSE HER MOTHER TO PASS AWAY. ON (B)(6) 2016 - PER PHONE CONVERSATION WITH COMPLAINANT, PATIENT HAD PICC LINE PLACED AND HAD BEEN USING IT FOR APPROXIMATELY 2 WEEKS WITHOUT ISSUE. THE COMPLAINANT STATES THE PATIENT PASSED AWAY FROM CARDIAC ARREST BUT DID NOT KNOW THE CAUSE OF THE CARDIAC ARREST. PATIENT DID TELL COMPLAINANT THAT SHE HAD SOME DISCOMFORT IN HER SHOULDERS AND HAND AFTER PLACEMENT OF THE SECOND PICC LINE BUT COMPLAINANT IS UNSURE IF THESE DISCOMFORTS SUBSIDED OR NOT. COMPLAINANT EXPRESSED CONCERN ABOUT PICC LINES BEING PLACED IN THE HEART (IT IS UNKNOWN WHY OR HOW COMPLAINANT CAME TO THIS CONCLUSION) AND WHETHER THIS COULD HAVE BEEN THE CAUSE OF THE PATIENT¿S CARDIAC ARREST AS THE PATIENT DID NOT HAVE A HISTORY OF HEART PROBLEMS. INFORMED COMPLAINANT THAT PICC LINES ARE NOT INTENDED TO BE PLACED IN THE HEART BUT THAT THE TIP OF THE CATHETER RESTS IN THE SUPERIOR VENA CAVA. AFTER A

  Patient problems: Cardiac Arrest; Death; Discomfort; Numbness; Tingling

  MAUDE report 5619647 ↗