PowerPICC SOLO CK000637Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741128233), received between Sep 18, 2017 and May 17, 2018 — classified as 3 malfunctions.

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

• MalfunctionMay 17, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE PICC NURSE PLACED THE PICC AROUND MIDNIGHT AND FLUSHED THE LINE. ON THE MORNING OF (B)(6) 2018 THE PICC NURSE WENT TO FLUSH THE LINE AFTER INFUSION AND THE PICC LEAKED AT THE HUB. THE FACILITY STATED THAT THE "HUB IS ACTUALLY BROKEN/CRACKED." THE PICC LINE WAS REMOVED AND ANOTHER WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522272 ↗
• MalfunctionFeb 7, 2018Crack; Leak/Splash

  THE FACILITY REPORTED TO THE SALES REP THAT DURING PRIMING THE PICC WITH SALINE PRIOR TO PLACEMENT, VASCULAR ACCESS NURSE NOTICED SALINE APPEARED TO EXIT THE CATHETER FROM A SITE OTHER THAN THE CATHETER TIP. IT WAS STATED THE NURSE DISCONNECTED SYRINGE AND RECONNECTED TO ASSURE ALL CONNECTIONS WERE CORRECT AND NOTICED A VERTICAL CRACK IN THE CATHETER HUB. ON ATTEMPT TO SHOW STAFF WHERE CATHETER WAS CRACKED IT WAS REPORTED THAT THE CATHETER HUB SPLIT AT THE COLORED BIFURCATION. ANOTHER KIT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7250186 ↗
• MalfunctionSep 18, 2017Split

  PER MEDWATCH REPORT, THE FACILITY REPORTED: "PATIENT PREPPED AND DRAPED PER PROCEDURE PROTOCOL. RIGHT BRACHIAL VEIN ACCESSED WITH 21G NEEDLE REMOVED OVER WIRE. 5FR MICRO-INTRODUCER ADVANCED OVER 0.018 GUIDEWIRE. GUIDEWIRE REMOVED FROM MICRO-INTRODUCER AND MICRO-INTRODUCER DILATOR CAPPED OFF WITH DEAD END CAP. PICC PREPPED FOR INSERTION. DILATOR REMOVED FROM BREAKAWAY SHEATH. PICC INSERTED WITHOUT ISSUE. PICC TIP PLACEMENT VERIFIED WITH SHERLOCK AND 3CG. UPON TRYING TO REMOVE THE BREAKAWAY SHEATH ONE OF THE RED FINGER PIECES THAT NORMALLY IS USED TO SPLIT THE SHEATH AND PULL IT OUT BROKE AWAY FROM THE SHEATH. SHEATH PORTION REMAINED INTACT AND WAS REMOVED OVER THE EXTERNAL PORTION OF THE PICC LINE THEN SPLIT AND REMOVED AWAY FROM THE LINE WITH THE REMAINING RED FINGER PIECE. BREAKAWAY SHEATH VISUALLY INSPECTED NO PIECES MISSING. PICC LINE SECURED AND DRESSED PER POLICY. PCXR OBTAINED THAT INCLUDED THE RIGHT ARM. PICC LINE APPEARS TO BE IN GOOD POSITION AND NOTHING ELSE NOTED ON X-RAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872100 ↗