PowerGlide F122080TRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741142680), received between Mar 12, 2021 and May 1, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Material Frayed

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PICU FELLOW NOTED THAT THE GUIDEWIRE BROKE INSIDE THE PATIENT DURING A MIDLINE PLACEMENT ATTEMPT. THE GUIDEWIRE WAS SUCCESSFULLY RETRIEVED, AND AN X-RAY CONFIRMED COMPLETE REMOVAL. THERE WAS NO FURTHER ESCALATION OR HARM CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057675 ↗
• MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED NEEDLE FULLY DETACHED FROM POWERGLIDE UPON INSERTION WHEN CLINICIAN WENT TO WITHDRAWAL IT. NEEDLE WAS LEFT ATTACHED TO THE BLUE WINGS AND IN THE CATHETER LEFT BEHIND IN THE PATIENT. NEEDLE AND CATHETER WAS TAKEN OUT BY THE PLACING NURSE WITHOUT FURTHER INCIDENT. NO SERIOUS INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715375 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED VIA MEDSUN, 22G POWERGLIDE CATHETER MALFUNCTION. CATHETER SHEARED UPON INSERTION ATTEMPT. GENERAL FORCEPS NEEDED TO REMOVE DISTAL END OF SHEARED CATHETER. DISTAL CATHETER TIP INTACT UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646742 ↗
• InjuryApr 24, 2025Break; Break

  IT WAS REPORTED BY MEDWATCH VASCULAR ACCESS ATTEMPTED A POWERGLIDE PLACEMENT. THEY WERE UNABLE TO REMOVE WIRE/NEEDLE AFTER ADVANCING THE CATHETER. THEY ATTEMPTED TO THEN REMOVE CATHETER AND NOTICED CATHETER APPEARED BROKEN JUST ABOVE HUB. THE CATHETER AND WIRE/NEEDLE NEEDED SURGICALLY REMOVED AT BEDSIDE. ONCE REMOVED THE CATHETER WAS FOUND TO BE SCRUNCHED OVER WIRE/NEEDLE BUT PURPLE TIP INTACT. UNCLEAR IF THIS WAS AN INSERTION PROCEDURE ISSUE OR A DEFECTIVE PRODUCT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21904674 ↗
• MalfunctionApr 22, 2025Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDWATCH "24F POWERGLIDE CATHETER BEING USED FOR ULTRASOUND IV NEEDLE INSERTION. WHILE ADVANCING PLASTIC CATHETER OVER GUIDEWIRE, UNABLE TO COMPLETELY REMOVE THE DEVICE. DEVICE ULTIMATELY REMOVED WITH PLASTIC CATHETER BECOMING AND "ACCORDION" ON ITSELF, NEEDLE NOT SAFELY RETRACTED COMPLETELY. DEVICE WAS NOT KEPT DUE TO THE EXPOSED NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881849 ↗
• MalfunctionFeb 6, 2025Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, THE GUIDEWIRE WAS DEPLOYED AND THEN WOULD NOT COME OUT OF THE DEVICE. DEVICE AND GUIDEWIRE WERE STUCK. CAREFULLY REMOVED AND ENTIRETY OF 8CM INTACT BUT CURLED. NO OTHER INFORMATION IS KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319122 ↗
• MalfunctionJan 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, AFTER INSERTION, THE VAT RN WAS ATTEMPTING TO DEPLOY THE GUIDEWIRE-UPON DEPLOYING THE GUIDEWIRE THE CATHETER WOULD NEED FEED OVER THE GUIDEWIRE¿THE NURSE TRIED TO RETRACT THE GUIDEWIRE, BUT IT WOULDN¿T RETRACT. UPON REMOVAL, SHE NOTED THAT THE GUIDEWIRE WAS COILED AT THE END OF THE CATHETER AND THE CATHETER WAS CRINKLED. THERE WAS NO VARIATION OR DEVIATION FROM INSERTION PRACTICES THAT WERE IDENTIFIED, AS MULTIPLE VAT RNS WERE PRESENT. PATIENT WAS STUCK AGAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146301 ↗
• MalfunctionSep 19, 2024Component Incompatible; Difficult to Remove; Component Incompatible; Difficult to Remove

  IT WAS REPORTED BY CUSTOMER "I HAD A FAULTY POWER GLIDE PRO MIDLINE. 22G 8 CM. I NAVIGATED OVER HALF THE MIDLINE INTO THE VEIN BY SLOWLY WALKING IT IN USING ULTRASOUND THEN DEPLOYED THE WIRE WITHOUT RESISTANCE AND THEN ADVANCED THE BLUE WINGS, SO THE CATHETER PUSHED OFF. RELEASED THE TOURNIQUET THROUGH THE DRAPE AND WENT TO REMOVE THE WIRE HOUSING DEVICE AND THE WIRE WOULD NOT COME OUT OF THE CATHETER. I PULLED THE CATHETER SLIGHTLY OUT OF SKIN HOWEVER THERE WAS RESISTANCE, SO I PAUSED. I THEN RE ASSESSED THE VESSEL AND IT LOOKED THE SAME SIZE AS WHEN I STARTED THE PROCEDURE, NO VENOUS SPASM NOTED. I THEN ATTEMPTED TO REMOVE THE WIRE AGAIN, BUT IT WOULD NOT COME OUT. I THEN PULLED BOTH THE WIRE AND CATHETER A LITTLE HARDER AND PINCHED JUST PAST WHERE THE HUB MEETS THE SOFT CANNULA. I THEN CONTINUED A FIRM CONTINUES PULL AND WAS ABLE TO REMOVE BOTH ALL AT ONCE. INCIDENT OCCURRED (B)(6) 2024 AT 12:50. HAD TO RE ATTEMPT FOR ACCESS. WAS NOT SUCCESSFUL WHICH LED PATIENT TO RECEIVE A CVAD. WE COULD NOT OBTAIN ACCESS HENCE THERE WAS DELAY IN TREATMENT AND PATIENT RECEIVED AN INTERNAL JUGULAR WITHIN A COUPLE HOURS OF MIDLINE ATTEMPT. NO IDEA WHY THE WIRE WOULD NOT COME OUT OF THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256897 ↗
• MalfunctionSep 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT HAIR FOUND IN PACKAGING OF THE PRODUCT. THE DEVICE WAS NOT INSERTED. IT COULDN'T BE USED, THE HAIR WAS FOUND WHEN THEY OPENED IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197181 ↗
• InjuryJul 2, 2024Break; Break

  IT WAS REPORTED THAT POWERGLIDE 8CM CATHETER FOUND TO BE BROKEN (COMPLETE BREAK) WHEN REMOVED FROM PATIENT ARM. NO HARM TO PATIENT - ABLE TO REMOVE BROKEN LUMEN FROM ARM. NO SURGERY REQUIRED, ALL BROKEN PIECES ACCOUNTED FOR. ADDITIONAL INFORMATION RECEIVED: THE PATIENT DID NOT REQUIRE SURGERY TO REMOVE THE BROKEN PIECE. ALL THE MISSING PIECES WERE RETRIEVED AND ACCOUNTED FOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 19656524 ↗
• InjuryJun 12, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE CATHETER AND TIP OF WIRE SHEARED IN PATIENT'S ARM. PATIENT REQUIRED SURGICAL PROCEDURE TO REMOVE RETAINED COMPONENT. PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DURING SURGICAL PROCEDURE WHEN REMOVING SHEARED CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19522191 ↗
• InjuryMar 14, 2024Improper or Incorrect Procedure or Method; Activation Problem; Improper or Incorrect Procedure or Method; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT 22G/8CM ¿ BEFORE INSERTION, CHECKED THE GUIDEWIRE, RETRACTED WELL. WHEN INSERTED IN PATIENT, ADVANCED GUIDEWIRE BUT COULDN¿T PULL BACK THE SYSTEM. SEEMED TO GET STUCK AND WITH EFFORT, BROKE THE WIRE AND CATHETER IN PATIENT. HAD TO CALL IR, CAME BY BEDSIDE AND TOOK AWHILE TO RETRIEVE THEW HOLE WIRE AND CATHETER, CATHETER CAME OUT WRINKLED. GAVE LOTS OF LIDOCAINE ON THE AREA¿ ADDITIONAL INFORMATION RECEIVED 2/29/2024: IT WAS REPORTED ANOTHER POWERGLIDE WAS PLACED IN A DIFFERENT VESSEL, 20G. THE CATHETER APPEARED TO BE PERFORATED AND DETACHED BETWEEN THE CATHETER AND THE JUNCTION OF THE CATHETER HUB. IR EXTRACTED THE WIRE AND CATHETER WITH FORCEPS. PATIENT WAS NOT HARMED OTHERWISE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18909545 ↗
• MalfunctionFeb 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER ¿RN & I WERE SEEING A PATIENT TODAY. POWERGLIDE PRO EXAMINED PRIOR TO INSERTION AND FOUND TO BE FULLY INTACT. 2 VAT RNS AND BEDSIDE RN PRESENT FOR INSERTION AND FOUND THAT TECHNIQUE WAS APPROPRIATE. POWERGLIDE PRO INSERTED WITH NO DIFFICULTY UNTIL AFTER DEPLOYMENT OF GUIDE WIRE. SUCCESSFUL GUIDEWIRE DEPLOYMENT BUT IMMEDIATE INABILITY TO THREAD CATHETER OFF OF THE DEVICE LED TO IMMEDIATE CESSATION OF ATTEMPT TO THREAD AND ATTEMPT WAS MADE TO RETRACT GUIDEWIRE WITHOUT SUCCESS. ULTIMATELY, PROCEDURE WAS ABORTED AND ATTEMPTED TO PULL THE LINE FROM PATIENT'S ARM WITH EXTREME DIFFICULTY AND PATIENT REPORTED EXTREME PAIN. LINE SUCCESSFULLY REMOVED FROM PATIENT AND IS INTACT WITH NO RESIDUAL CATHETER LEFT IN PATIENT. ARM EXAMINED UNDER ULTRASOUND, FOUND WITH NO COMPLICATIONS TO VASCULATURE THAT WAS ATTEMPTED FOR CANNULATION. SMALL AREA OF ECCHYMOSIS AT SITE REMOVAL.¿ 1/8/2024 ¿ ONE DEVICE WAS RETURNED FOR EVALUATION. THE CATHETER WAS FOUND BROKEN AND THE GUIDEWIRE REVEALED SEVERAL MISALIGNED COILS ON THE DISTAL TIP

  Patient problems: Ecchymosis; Pain

  MAUDE report 18628266 ↗
• InjuryJul 20, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER THAT CATHETER SHEARED WHEN PULLED BACK ONTO DEVICE AFTER ADVANCING CATHETER WINGS. PATIENT UNDERWENT SURGERY TO REMOVE SHEARED CATHETER. ADDITIONAL INFORMATION RECEIVED 7/14/2023: CUSTOMER REPORTS THAT THE BREAK WAS DISCOVERED WHEN SCANNING THE PATIENT'S ARM. X-RAY AND ULTRASOUND WERE USED TO CONFIRM CATHETER PIECE REMAINED IN THE PATIENT. PATIENT COMPLAINED OF PAIN AT THE SITE. ANOTHER POWERGLIDE MIDLINE WAS PLACED IN THE OTHER ARM, AND THEY HAD TO STOP OTHER MEDS TO GIVE THE MED THEY NEEDED GIVE. CATHETER PIECE WAS SUCCESSFULLY REMOVED VIA SURGERY AT BEDSIDE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 17366756 ↗
• MalfunctionJun 22, 2023Material Frayed; Material Frayed

  CUSTOMER REPORTED THAT DURING PLACEMENT, GUIDEWIRE WENT IN SMOOTHLY. WHEN CLINICIAN WENT TO THREAD THE CATHETER OFF OF THE NEEDLE, THEY FELT RESISTANCE. THEY PULLED THE CATHETER BACK AND THEN PULLED BACK THE GUIDEWIRE WITH THE PURPLE ADVANCER. WHEN THEY PULLED THE WHOLE DEVICE OUT OF THE PATIENT, THEY NOTICED THE GUIDEWIRE WAS BENT. AS THEY WERE LOOKING AT THE GUIDEWIRE, THEY NOTICED THAT IT LOOKED UNRAVELED, AND IT THEN JUST FELL OFF ONTO THE GROUND. PATIENT HAD TO BE RE-STUCK. SECOND INSERTION WAS SUCCESSFUL. ADDITIONAL INFO RECEIVED ON 17-JUL-2023: NO PIECES RETAINED IN THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182606 ↗
• MalfunctionApr 27, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER "PLACING POWERGLIDE PRO RIGHT BASILIC UNDER ULTRASOUND. DURING INSERTION PATIENT ACTIVE, TWISTING ARM. CANNULATED VEIN WITH NEEDLE, FULLY ADVANCED NEEDLE, RELEASED GUIDE WIRE, ADVANCED CATHETER. ATTEMPTED TO REMOVE GUIDEWIRE AND RESISTANCE NOTED. ATTEMPTED TO REMOVE CATHETER WITH GUIDE WIRE AND RESISTANCE NOTED. PATIENT BROUGHT TO IGT. UNDER FLUOROSCOPY IT WAS NOTED WIRE AND CATHETER HAD COILED BACK. CATHETER AND GUIDEWIRE REMOVED, INTACT, UNDER FLUOROSCOPY. NEW POWERGLIDE PRO INSERTED AFTER 2 MORE ATTEMPT BY RADIOLOGIST TO RIGHT BRACHIAL VEIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828690 ↗
• InjuryJun 29, 2022Break; Break

  IT WAS REPORTED VIA MEDWATCH "MIDLINE IV WAS ATTEMPTED THROUGH THE BRACHIAL/BASILIC VEIN. MIDLINE WAS IN PLACE (WITH FLASHBACK CONFIRMATION), AND GUIDE WIRE AND CATHETER WERE ADVANCED. WHILE ATTEMPTING TO REMOVE GUIDEWIRE, WIRE MET RESISTANCE, AND RN WAS UNABLE TO REMOVE THE WIRE. RN THEN ATTEMPTED TO REMOVE THE CATHETER AND AGAIN MET RESISTANCE. BOTH GUIDEWIRE AND CATHETER WERE STUCK, AND CATHETER WAS STRIPPED FROM WIRE AND DISLODGED IN PATIENT'S ARM. AT THIS TIME, RN STABILIZED WIRE AND CATHETER AND CONTACTED PROVIDERS. PATIENT HAD TO BE TAKEN FOR SURGICAL REMOVAL OF THE MIDLINE. MALFUNCTION OF MIDLINE DEPLOYMENT DEVICE IS HIGHLY SUSPECTED."

  Patient problems: Foreign Body In Patient

  MAUDE report 14861130 ↗
• MalfunctionMar 12, 2021Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "MIDLINE ATTEMPT BY ME RN IV TEAM WITH ULTRASOUND-GUIDED BARD POWERGLIDEPRO MIDLINE CATHETER 22G, 8CM LOT# REEU1755 IN PT'S RIGHT CEPHALIC VEIN. AFTER VEIN CANNULATED AS EVIDENCED BY FLASH AND U/S, AND GUIDEWIRE THREADED, I ATTEMPTED TO PULL ENTIRE DEVICE INCLUDING NEEDLE/GUIDEWIRE FROM THE CATHETER, BUT MET RESISTANCE. NOT WANTING TO CAUSE DAMAGE TO THE VEIN, RN IV TEAM CONSULTED. UPON ASSESSMENT, MANUFACTURER MALFUNCTION/CATHETER SEPARATION FROM NEEDLE SUSPECTED. TOURNIQUET APPLIED TO RIGHT UPPER ARM CONSIDERING POSSIBLE RISK OF CATHETER FLOATING/CAUSING EMBOLI. PRIMARY RN PAGED PRIMARY, TRAUMA TEAM, AND DR. REPORTED TO BEDSIDE. MD ASSESSED SITUATION AND WAS ABLE TO PULL DISLODGED CATHETER AND ENTIRE MIDLINE DEVICE FROM PT'S ARM WITH TWEEZERS AT 14:40. PRESSURE HELD AT SITE, HEMOSTASIS ACHIEVED; PETROLEUM GAUZE, 4X4, AND TRANSPARENT DRESSING APPLIED TO SITE. SITE SOFT UPON PALPATION, NO S/S HEMATOMA. ALL COMPONENTS OF POWERGLIDE INCLUDING PACKAGING KEPT AND WILL BE TURNED OVER TO RISK MANAGEMENT" ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: WHAT THEYRE BEING TREATED FOR: SDH/SAH WITH MIDLINE SHIFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474636 ↗