PowerGlide Midline Catheter M120100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741075322), received between Dec 21, 2015 and May 24, 2017 — classified as 3 injuries, 7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2017Difficult to Remove; Failure to Disconnect

  PER SALES REP, THE FACILITY REPORTED THAT THE RN COULD NOT DISCONNECT THE HOUSING FROM THE CATHETER. IT WAS STATED THAT THE RN FELT RESISTANCE WHEN TRYING TO REMOVE THE COMPLETE DEVICE (HOUSING, CATHETER, AND WIRE) FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6589384 ↗
• InjuryFeb 23, 2017Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  PER SALES REPRESENTATIVE, FACILITY REPORTED THAT ONE OF THEIR NURSES THAT WHO IS PICC LINE CERTIFIED AND COMPETENT IN MIDLINE INSERTIONS, ATTEMPTED TO PLACE A 20G POWERGLIDE MIDLINE IN ONE OF THEIR ER PATIENTS. THE INSERTION WAS UNDER ULTRASOUND GUIDANCE BY A LICENSED ULTRASOUND TECH. IT WAS SUCCESSFUL WITH THE IMAGING SHOWING THE NEEDLE AND THE DEPLOYED GUIDEWIRE WITHIN THE LUMEN OF THE VEIN. THIS WAS WITNESSED BY THE NURSE, THE TECH AND THE ER PHYSICIAN. AT THE LAST POINT OF ADVANCING THE CATHETER, THE NURSE ENCOUNTERED SOME RESISTANCE, AND IN HER WORDS, ¿FELT SOMETHING WASN¿T RIGHT¿. THE NURSE WAS UNABLE TO DETACH THE CATHETER FROM THE NEEDLE. THE NURSE ATTEMPTED TO REMOVE THE WHOLE MIDLINE AS A UNIT FROM THE PATIENT¿S ARM. IT THEN SHEARED OFF APPROXIMATELY 8 CM. AN X-RAY WAS PERFORMED AND IT WAS FOUND THAT THERE WAS APPROXIMATELY 8 CM OF CATHETER IN THE SUBCUTANEOUS PORTION OF THE PATIENT¿S ARM. NO PATIENT HARM WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6355183 ↗
• MalfunctionNov 18, 2016Bent

  ON 11/7/2016- PER SALES REPRESENTATIVE THE FACILITY REPORTED, WHEN THE PRODUCT WAS INITIALLY TAKEN OUT OF THE PACKAGE, THE WIRE FELT A LITTLE STIFF, AS IF CAUGHT ON SOMETHING BUT THEN AFTER ADVANCED FINE AND CLINICIAN WAS ABLE TO MOVE FORWARD TO ACCESS THE PATIENT. IT WAS STATED THAT WHEN THE CLINICIAN ADVANCED THE NEEDLE, (CLEARLY VISUALIZED WITH ULTRASOUND) AND ¿EVERYTHING SEEMED NORMAL¿. WHEN THE WIRE WAS BEING ADVANCED THE CLINICIAN STATED THAT SOMETHING DID NOT FEEL RIGHT, SIMILAR TO HOW IT MIGHT FEEL IF THE NEEDLE WAS NOT IN THE VESSEL. THE CLINICIAN REPORTEDLY, STOPPED THE PROCEDURE WITH NEEDLE AND WIRE FULLY DEPLOYED INSIDE OF VESSEL. WHEN RETRACTING ENTIRE DEVICE, THE NEEDLE CAME OUT HOWEVER THE WIRE WAS STUCK INSIDE OF THE PATIENT. IT WAS REPORTED THAT THE WIRE WAS STILL CONNECTED TO THE DEVICE SO THE CLINICIAN DID NOT MOVE THE DEVICE ANY FURTHER AND CALLED IR TO HELP WITH RETRACTING WIRE. IR PA WAS ABLE TO MANEUVER THE WIRE AND SAFELY PULLED THE WIRE OUT OF THE PATIENT. PA COMMENTED THAT THE WIRE DID NOT APPEAR TO BE IN THE VESSEL, SUSPECT MAYBE IN THE SOFT TISSUE. WHEN VIEWING THE DEVICE/WIRE, IT WAS STATED THAT THE MAIN WIRE REMAINED STRAIGHT BUT THE COILED WIRE WAS EX

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6115310 ↗
• MalfunctionNov 18, 2016Kinked

  ON (B)(6) 2016 - FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT DURING A PROCEDURE THE GUIDEWIRE "CRUMPLED" UP ON ITSELF AND KINKED THE CATHETER. THE CATHETER WAS REMOVED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6113306 ↗
• MalfunctionAug 31, 2016Break; Improper or Incorrect Procedure or Method

  PER SALES REPRESENTATIVE, FACILITY REPORTED THAT THEY HAD AN EVENT REPORTED REGARDING BREAKAGE OF BARD MIDLINE POWER GLIDE AT THE PINK END OF THE PURPLE HUB. NO HARM TO PATIENT. THE MIDLINE WAS REMOVED IN ITS ENTIRETY, NO RETAINED CATHETER. PATIENT REPORTED HE HAD GOTTEN HIS ARM STUCK ON WHEELCHAIR WHICH MAY HAVE CONTRIBUTED TO THE BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5919216 ↗
• MalfunctionMay 11, 2016Material Frayed; Uncoiled; Physical Resistance

  ON 4/19/16 - COMPLAINANT REPORTED THAT A THE WIRE FROM A 20G X 10CM MIDLINE CATHETER FRAYED. THEY STATED THAT THE WIRE SEEMED TO UNCOIL AND THEN FRAY. THE PHYSICIAN DID NOT PULL THE WIRE BACK INTO THE NEEDLE BECAUSE ONCE HE FELT RESISTANCE, HE DID NOT GO ANY FARTHER. THE PATIENT WAS NOT HARMED OR INJURED.

  Patient problems: No Patient Involvement

  MAUDE report 5648812 ↗
• MalfunctionMay 3, 2016Leak/Splash

  (B)(4) ENGINEERS FOUND THAT AN EXTRA POWERGLIDE SAMPLE RETURNED FOR EVALUATION LEAKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5625685 ↗
• MalfunctionMar 24, 2016Material Integrity Problem

  PER SALES REPRESENTATIVE, A FACILITY REPORTED THAT WHEN A NURSE WAS PLACING A POWERGLIDE, THE GUIDEWIRE "PUSHED OFF" AND THE CATHETER WOULD NOT THREAD. THE NURSE CALLED IN A SURGEON WHO TUGGED ON IT AT WHICH POINT THE CATHETER SHEARED AND HAD TO BE REMOVED.

  Patient problems: No Information

  MAUDE report 5524734 ↗
• InjuryFeb 1, 2016Physical Resistance

  IT WAS REPORTED THAT A CUSTOMER EXPERIENCED SIGNIFICANT RESISTANCE WHEN SWITCHING THE CANNULATION OF THE FIRST PORTION OF THE CATHETER INSTALLED ON (B)(6) 2016. ALLEGEDLY 4 CM WAS LEFT IN THE VEIN OF A PATIENT WHEN REMOVING THE POWERGLIDE. AS TRANSCRIBED FROM CUSTOMER FROM FRENCH: "PLEASE UNDERSTAND THAT SINCE WE HAD A RESISTANCE TO CANNULATION, THE CATHETER MOVED. WE COULD CANNULATE THE 2ND PART AND HAD TO REMOVE THE CATHETER. WHEN REMOVING THE CATHETER, A SLIGHT RESISTANCE WAS OBSERVED AND 4 CM REMAINED IN THE VEIN. THE RESULT WAS THAT THE VASCULAR SURGERY ADVISED IN THE FILE, THAT THE PATIENT SHOULD PERHAPS GO TO ANGIOGRAPHY TO REMOVE THE 4 CM CATHETER THAT REMAINED IN HIS VEIN. PATIENT IS AWAITING A PROCEDURE TO REMOVE THE 4 CM."

  Patient problems: Foreign Body In Patient

  MAUDE report 5402683 ↗
• InjuryDec 21, 2015Retraction Problem; Malposition of Device

  PER SALES REPRESENTATIVE, FACILITY REPORTED THAT A 20G POWERGLIDE ALLEGEDLY SHEARED IN A PATIENT. CONTACT REPORTED THAT THE PATIENT IS OK BUT WILL NEED TO GO TO SURGERY TO HAVE IT REMOVED. FACILITY WAS ABLE TO LOCATE THE 2CM LEFT IN THE PATIENT VIA X-RAY. CONTACT STATED THAT THE POWEGLIDE GAVE GREAT BLOOD RETURN AND THAT INSERTION WAS FINE BUT WHEN SHE WENT TO RETRACT IS WHEN SHE FELT SOMETHING WAS STRANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5315093 ↗