PowerPICC CK000539Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741105197), received between Jul 21, 2017 and Jul 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 16, 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.

• MalfunctionJul 28, 2017Malposition of Device

  FACILITY REPORTED THAT PICC WAS PLACED ON (B)(6) 2017, IN THE RIGHT BASILICA VEIN. PLACEMENT WAS "UNEVENTFUL", 5FR TRIPLE LUMEN PICC, 38 CM LONG WITH 2 CM EXPOSED. PICC PLACEMENT VERIFIED WITH 3CG. TWELVE DAYS POST PLACEMENT NURSE WAS INFORMED THAT THE PICC "STOPPED WORKING" AND CATHFLO DID NOT HELP. PICC WAS STILL 2 CM OUT. CHEST X-RAY WAS DONE TO CHECK FOR MALPOSITIONING. THE READING WAS PROXIMAL SVC. AN X-RAY OF THE ARM WAS DONE TO SEE IF IT WAS A GOOD IDEA FOR THE PICC TEAM TO REPLACE. A SINGLE VIEW IS OBTAINED, CENTERED OVER THE MID AND LATERAL RIGHT CHEST INCLUDING THE RIGHT ARM. PICC LINE IS SEEN, TIP EXTENDING TO THE MID SUPERIOR VENA CAVA. THERE IS A MODERATE LOOP IN THE MEDIAL BICEP REGION WITH AN 'S' SHAPED CURVATURE OF APPROXIMATELY 4CM. THIS COULD ACCOUNT FOR AN 8 CM DISCREPANCY OF LENGTH FROM THE EXPECTED POSITION. THERE IS NO KINKING OR CATHETER FRAGMENTATION. WITH THE PREVIOUS PICC MALPOSITION IN 12-24 HOURS AFTER REPLACEMENT, INTERVENTIONAL RADIOLOGY DECIDED TO PLACE A NEW PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750321 ↗
• MalfunctionJul 21, 2017Device Inoperable; Malposition of Device

  FACILITY REPORTED TO THE SALES REP THAT THE PICC MALPOSITIONED AND STOPPED WORKING AFTER 12 DAYS AND REQUIRED REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED, BUT HAS BEEN REQUESTED.

  Patient problems: No Information

  MAUDE report 6733671 ↗