PowerPICC SOLO CK000408Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741096273), received between Nov 18, 2016 and Aug 10, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2022Component Incompatible; Component Incompatible

  IT WAS REPORTED "PICC WIRE WILL NOT THREAD THROUGH INTRODUCER NEEDLE. ONCE THE NEEDLE WAS REMOVED, FLUSHED FINE, WIRE STILL WOULDN'T ADVANCE. NURSE CUT THE TIP OF THE WIRE OFF TO TRY TO ADVANCE AGAIN AND IT WENT THROUGH THE NEEDLE FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204040 ↗
• MalfunctionAug 13, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED PREPROCEDURE, CALIBRATED SHERLOCK, INTRAVASCULAR BASELINE PRESENT, AFTER ACCESS GAINED, CALIBRATED SHERLOCK, INTRAVASCULAR BASELINE PRESENT, INSERTED PICC INTO VEIN VIA INTRODUCER, INTRAVASCULAR WAVEFORM DISAPPEARED FROM SCREEN, POSITIONED PICC VIA SHERLOCK TECHNOLOGY, THEN ADJUSTED BASELINE WAVEFORM APP TO BRING INTRAVASCULAR WAVEFORM BACK ONTO THE SCREEN, UNABLE TO RETURN INTRAVASCULAR WAVEFORM TO THE SCREEN, CHECKED CONNECTIONS, ALL CONNECTED. REMOVED WIRE TO CONFIRM WITH CXR, WHEN WIRE REMOVED FROM PT VEIN, INTRAVASCULAR BASELINE REAPPEARED, READVANCED WIRE INTO PICC, TO CONFIRM TIP PLACEMENT, WAVEFORM DISAPPEARED FROM SCREEN, WIRE REMOVED AND CXR OBTAINED. DELAY OF USE OF PICC NOTED, AS PT HAD TO WAIT FOR CXR. ADDITIONAL INFORMATION RECEIVED 06/26/2020: PLACEMENT INFO: WAVEFORM DISAPPEARED FROM THE SCREEN, WOULD NOT REAPPEAR OR BE ADJUSTED WITH BASELINE ADJUSTMENT APP, RETURNED TO VIEW WHEN WIRE REMOVED FROM PICC, BASELINE WAS PRESENT ON PREPROCEDURE CALIBRATION., ALL CONNECTIONS CHECKED, LINE FLUSHED WITH SALINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405214 ↗
• MalfunctionNov 14, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GRAY INTRODUCER IN THE PICC KIT WAS TOO FLEXIBLE TO INSERT INTO SEVERAL PATIENTS. IT WAS STATED IT BENT TO A 90% ANGLE ON ATTEMPTED INSERTION. THE RN SAID THE INTRODUCER FROM THE EXTRA MICRO INTRODUCER KIT (ORANGE IN COLOR) IS MUCH STIFFER AND EASIER TO INSERT IN MUSCULAR INDIVIDUALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323858 ↗
• InjuryFeb 7, 2018Difficult to Insert; Difficult to Remove; Physical Resistance

  IT WAS REPORTED BY FACILITY THAT THE NURSE ATTEMPTED TO INSERT A PICC INTO A PATIENT¿S LEFT AC VEIN, MET RESISTANCE, AND WAS THEN UNABLE TO WITHDRAW THE GUIDE WIRE. IT WAS STATED THE RN SECURED THE GUIDE WIRE, ASSESSED THE PATIENT AND IT WAS DETERMINED THAT THE WIRE WOULD REQUIRE SURGICAL INTERVENTION IN ORDER TO REMOVE IT.

  Patient problems: No Code Available

  MAUDE report 7250083 ↗
• MalfunctionNov 18, 2016Flushing Problem; Knotted; Sticking; Physical Resistance

  (B)(6) 2016- PER SALES REPRESENTATIVE, FACILITY REPORTED THAT THE PICC WAS PLACED WITH SLIGHT RESISTANCE THEN THREADED EASILY; SHERLOCK AND EKG TECHNOLOGY VERIFIED PLACEMENT BUT THEN CATHETER WOULD NOT FLUSH AND THERE WAS NO BLOOD RETURN. IT WAS STATED THAT IN AN ATTEMPT TO PULL THE PICC OUT IT BECAME STUCK. THE PHYSICIAN WAS NOTIFIED AND A 5 FR DILATOR WAS PLACED OVER THE PICC AND THEN THE DILATOR WAS REMOVED. IT WAS STATED THAT THE PICC WAS PULLED AND IT CAME OUT INTACT WITH A SMALL KNOT AT THE END. A PRESSURE DRESSING WAS APPLIED.

  Patient problems: No Information

  MAUDE report 6115181 ↗