PowerPICC Catheter 3175355Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741027703), received between Aug 15, 2016 and Aug 17, 2018 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2018Obstruction of Flow

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD AN ISSUE WITH THEIR 5FR SINGLE LUMEN PICCS NOT FLUSHING/PASSING THE WIRE ON PLACEMENT. THEY STATE THAT THERE SEEMS TO BE A "BALL" OR SOMETHING INSIDE THE PICC OCCLUDING IT ROUGHLY MIDWAY DOWN THE LINE. THEY HAVE HAD ISSUES WITH 2 THAT THEY PLACED AND THEN 3 MORE THAT THEY TESTED BEFORE PLACING. THE TWO PICCS THAT WERE PLACED WERE REMOVED DUE TO OCCLUSIONS. IT WAS STATED THAT THERE WAS NO PATIENT HARM. THIS FILE ADDRESSES THE FIFTH OF THE 5 DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794613 ↗
• MalfunctionAug 17, 2018Obstruction of Flow

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD AN ISSUE WITH THEIR 5FR SINGLE LUMEN PICCS NOT FLUSHING/PASSING THE WIRE ON PLACEMENT. THEY STATE THAT THERE SEEMS TO BE A "BALL" OR SOMETHING INSIDE THE PICC OCCLUDING IT ROUGHLY MIDWAY DOWN THE LINE. THEY HAVE HAD ISSUES WITH 2 THAT THEY PLACED AND THEN 3 MORE THAT THEY TESTED BEFORE PLACING. THE TWO PICCS THAT WERE PLACED WERE REMOVED DUE TO OCCLUSIONS. IT WAS STATED THAT THERE WAS NO PATIENT HARM. THIS FILE ADDRESSES THE FOURTH OF THE 5 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794538 ↗
• MalfunctionAug 17, 2018Positioning Problem

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD AN ISSUE WITH THEIR 5FR SINGLE LUMEN PICCS NOT FLUSHING/PASSING THE WIRE ON PLACEMENT. THEY STATE THAT THERE SEEMS TO BE A "BALL" OR SOMETHING INSIDE THE PICC OCCLUDING IT ROUGHLY MIDWAY DOWN THE LINE. THEY HAVE HAD ISSUES WITH 2 THAT THEY PLACED AND THEN 3 MORE THAT THEY TESTED BEFORE PLACING. THE TWO PICCS THAT WERE PLACED WERE REMOVED DUE TO OCCLUSIONS. IT WAS STATED THAT THERE WAS NO PATIENT HARM. THIS FILE ADDRESSES THE SECOND OF THE 5 DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794488 ↗
• MalfunctionAug 17, 2018Complete Blockage

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD AN ISSUE WITH THEIR 5FR SINGLE LUMEN PICCS NOT FLUSHING/PASSING THE WIRE ON PLACEMENT. THEY STATE THAT THERE SEEMS TO BE A "BALL" OR SOMETHING INSIDE THE PICC OCCLUDING IT ROUGHLY MIDWAY DOWN THE LINE. THEY HAVE HAD ISSUES WITH 2 THAT THEY PLACED AND THEN 3 MORE THAT THEY TESTED BEFORE PLACING. THE TWO PICCS THAT WERE PLACED WERE REMOVED DUE TO OCCLUSIONS. IT WAS STATED THAT THERE WAS NO PATIENT HARM. THIS FILE ADDRESSES THE THIRD OF THE 5 DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794458 ↗
• MalfunctionAug 17, 2018Obstruction of Flow

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD AN ISSUE WITH THEIR 5FR SINGLE LUMEN PICCS NOT FLUSHING/PASSING THE WIRE ON PLACEMENT. THEY STATE THAT THERE SEEMS TO BE A "BALL" OR SOMETHING INSIDE THE PICC OCCLUDING IT ROUGHLY MIDWAY DOWN THE LINE. THEY HAVE HAD ISSUES WITH 2 THAT THEY PLACED AND THEN 3 MORE THAT THEY TESTED BEFORE PLACING. THE TWO PICCS THAT WERE PLACED WERE REMOVED DUE TO OCCLUSIONS. IT WAS STATED THAT THERE WAS NO PATIENT HARM. THIS FILE ADDRESSES THE FIRST OF THE 5 DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794453 ↗
• MalfunctionFeb 8, 2017Device Operates Differently Than Expected

  NURSE REPORTED THAT THEY HAD AN INTRODUCER FROM A PICC KIT THAT WOULD NOT BREAK. THE NURSE STATED THAT THEY HAD TO CLIP THE RED PLASTIC AND ON BOTH SIDES TO BE ABLE TO BREAK THE PEEL AWAY. THE INTRODUCER WAS ALSO CUT WITH SCISSORS FOR THE NURSE TO BE ABLE TO COMPLETE THE PICC PROCEDURE SUCCESSFULLY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6312135 ↗
• InjuryAug 15, 2016Detachment Of Device Component; Malposition of Device

  AS REPORTED BY THE NURSE VIA MEDWATCH: A BARD POWER PICC 55 CM 5 FRENCH WAS PLACED VIA RIGHT CEPHALIC. THE PICC WAS TRIMMED 10 CM AND POSITIONED AT 42 CM MARK. CHEST X-RAY TAKEN ON XXXX2016 SHOWED APPROPRIATE POSITION FOR PICC TIP. A THIN METALLIC OBJECT APPROXIMATELY 3 CM AT THE LEVEL OF THE RIGHT AXILLARY VEIN WAS NOTED BY RADIOLOGY ON XXX2016. INTERVENTIONAL RADIOLOGY CONSULTED AND RETRIEVED THE FOREIGN OBJECT UNDER FLUOROSCOPY. PICTURE TAKEN OF THE OBJECT BY THE RADIOLOGIST WAS CONSISTENT WITH TIP OF STYLET USED WITH POWER PICC. FBO WAS NOT KEPT."

  Patient problems: Foreign Body In Patient

  MAUDE report 5877521 ↗