PowerPICC CK000653Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741129568), received between Jun 23, 2017 and Jun 23, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2017Break; Detachment Of Device Component

  PER SALES REP, THE FACILITY REPORTED WHILE PLACING A PICC LINE, THE (RED) HANDLE BROKE OFF WHEN ATTEMPTING TO BREAK THE PEEL AWAY INTRODUCER. THE VASCULAR ACCESS NURSE WAS UNABLE TO GRASP THE REMAINING GREY PORTION OF THE INTRODUCER AND USED STERILE HEMOSTATS TO PEEL AWAY THE REMAINING CATHETER AT THE INSERTION SITE. THIS REPORT ADDRESS PATIENT ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663395 ↗
• MalfunctionJun 23, 2017Break

  PER SALES REP, THE FACILITY REPORTED WHILE PLACING A PICC LINE, THE (RED) HANDLE BROKE OFF WHEN ATTEMPTING TO BREAK THE PEEL AWAY INTRODUCER. THE VASCULAR ACCESS NURSE WAS UNABLE TO GRASP THE REMAINING GREY PORTION OF THE INTRODUCER AND USED STERILE HEMOSTATS TO PEEL AWAY THE REMAINING CATHETER AT THE INSERTION SITE. THIS REPORT ADDRESS PATIENT TWO.

  Patient problems: No Information

  MAUDE report 6663385 ↗
• MalfunctionJun 23, 2017Break; Detachment Of Device Component

  THE FACILITY REPORTED THAT ON (B)(6) 2017 WHILE PLACING A PICC LINE, THE (RED) HANDLE BROKE OFF WHEN ATTEMPTING TO BREAK THE PEEL AWAY INTRODUCER. THE VASCULAR ACCESS NURSE WAS UNABLE TO GRASP THE REMAINING GREY PORTION OF THE INTRODUCER AND USED STERILE HEMOSTATS TO PEEL AWAY THE REMAINING CATHETER AT THE INSERTION SITE. IT WAS STATED THAT THIS CAUSED EXCESSIVE TRAUMA AT THE INSERTION SITE. THIS REPORT ADDRESSES PATIENT THREE.

  Patient problems: Injury

  MAUDE report 6663366 ↗