PowerPICC CK000537Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741105173), received between Jul 21, 2017 and Jul 28, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2017Malposition of Device

  FACILITY REPORTED SINGLE LUMEN PICC WAS PLACED ON 6/6/17, WITH 3CG "PATIENT NOT IN A-FIB, LENGTH ADDED IN EFFORT TO ENSURE PICC REMAINED AT PLACEMENT". PICC MALPOSITIONED ON (B)(6) 2017, AND WAS REMOVED. A TUNNELED CVC WAS PLACED IN INTERVENTIONAL RADIOLOGY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750174 ↗
• MalfunctionJul 27, 2017Device Stops Intermittently; Device Inoperable

  FACILITY REPORTED PICC WAS PLACED ON (B)(6) 2017, IN THE RIGHT BASILIC VEIN. PICC WAS VERIFIED WITH CHEST X-RAY DUE TO ONSET AFIB. TIP WAS SEEN TO BE AT THE MID-LOWER SVC (2-3 CM ABOVE CAJ). NURSE WAS CALLED ON DAY 7 STATING PICC HAS HAD INTERMITTENT PROBLEMS AND HAD BEEN CATHFLOED TWO TIMES. ON DAY 7 THE PICC COMPLETELY STOPPED WORKING. CHEST X-RAY WAS DONE AND PICC WAS PROXIMAL SVC, 8 CM FROM CAJ. ORIGINAL DRESSING WAS INTACT AND PICC REMAINED 0 CM OUT. PICC WAS REPLACED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6746771 ↗
• MalfunctionJul 21, 2017Device Operates Differently Than Expected

  FACILITY REPORTED TO THE SALES REP THAT THE PICC WAS PLACED AND 4CM WAS ADDED 39CM/0 CM THINKING THE ADDED LENGTH WOULD KEEP IT IN PLACE. THE NEXT AM, PICC WAS NOT WORKING. CXR SHOWED PICC BACK IN PROXIMAL SVC. IR ENDED UP PUTTING IN A TUNNELED IJ. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6733656 ↗
• MalfunctionJul 21, 2017Device Operates Differently Than Expected

  FACILITY REPORTED TO THE SALES REP THAT THE PICC WAS PLACED IN THE RIGHT BASILIC, ARM CIRC 35CM, PICC 35 CM LONG/0 OUT ¿ CXR VERIFICATION @ MID TO LOWER SVC (2-3CM FROM CAJ). THE RN STATED THERE WAS ISSUES FOR SEVERAL DAYS PRIOR TO EXCHANGE AND HAD CATHFLOED IT. ON THE 7TH DAY IT COMPLETELY STOPPED WORKING. WHEN THEY CALLED ME 7 DAYS AFTER PLACEMENT I ASKED FOR A CXR. TIP WAS VERY PROXMAL SVC (8CM FROM CAJ) ORIGINAL DRESSING STILL INTACT, PICC REMAINS 0 CM OUT. PICC WAS EXCHANGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6733115 ↗