PowerGlide F118100TRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741142659), received between Feb 26, 2019 and May 19, 2026 — classified as 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (8 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Frayed

  IT WAS REPORTED BY MEDWATCH AFTER GUIDEWIRE WAS ADVANCED BY 60-70%, UNABLE TO ADVANCE ANY FURTHER DUE TO RESISTANCE. ON ATTEMPT TO PULL BACK, THERE WAS RESISTANCE AND WAS NOT ABLE TO PUSH FORWARD OR PULL BACK. WHEN FINALLY REMOVED, THE TIP OF THE GUIDE WIRE BROKE OFF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25220066 ↗
• MalfunctionMay 19, 2026Product Quality Problem

  IT WAS REPORTED MIDLINE PLACED IN PATIENT AND UPON REMOVAL OF DEVICE THE CLINICIAN NOTICED THERE WAS NO GUIDEWIRE EXTENDING BEYOND THE NEEDLE LIKE NORMAL. XRAY PERFORMED TO SEE IF WIRE WAS IN PATIENT, BUT NO EVIDENCE. UPON INSPECTING DEVICE, THEY NOTICED WHAT APPEARED TO BE WIRE SEMI-COILED IN THE BACK ON THE DEVICE. PATIENT NEEDED A NEW MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219748 ↗
• InjuryApr 28, 2026Material Frayed

  IT WAS REPORTED THE TIP FROM THE POWERGLIDE ACTUALLY GOT SHEERED OFF AND STUCK IN THE PATIENTS VESSEL. THE NURSE PLACED THE LINE "ONLY ADVANCED 60% OF THE WIRE¿, MET RESISTANCE ADVANCING THE CATHETER AND COULD NOT ADVANCE ANY FURTHER, PULLED THE LINE OUT WHOLE, DID NOT SEE THAT PART OF THE CATHETER WASN¿T ATTACHED FULLY BUT NOTICED LATER THAT SOMETHING WAS WRONG (AFTER THE NURSE PLACED A NEW LINE ON THE OTHER SIDE). HE STATED THE GUIDEWIRE WAS WEIRD, LOOKED LIKE THE END OF THE CATHETER WAS MISSING. ULTRASOUND WAS ORDERED, WHICH SAW THE CATHETER IN THE PATIENT¿S ARM. PATIENT WENT IN FOR AN ANGIOCATH PROCEDURE, AND THEY WERE UNABLE TO SEE THE CATHETER AT THAT TIME WHILE DOING THE PROCEDURE. THEY STATED THAT THEY DIDN¿T GO LOOKING FOR THE CATHETER, THE PATIENT WAS LATE DISCHARGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25016695 ↗
• MalfunctionApr 13, 2026Activation Problem

  IT WAS REPORTED SAFETY MECHANISM FAILED TO DEPLOY. NO PATIENT OR USER IMPACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24863015 ↗
• MalfunctionJan 5, 2026Activation Problem

  IT WAS REPORTED, THERE IS NO NEEDLE GUARD PRESENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957591 ↗
• MalfunctionDec 12, 2025Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation

  IT WAS REPORTED THAT A POWERGLIDE MIDLINE WAS INSERTED, BUT THE LUER LOCK HAD SOME FORM OF DEFECT. THE THREADS ON THE LUER LOCK WERE MALFORMED, PREVENTING CONNECTION OF A CLAVE OR EXTENSION LOOP TO THE MIDLINE CATHETER. ULTIMATELY, THE MIDLINE HAD TO BE PULLED AND REPLACED. NO SIGNIFICANT HARM WAS REPORTED; HOWEVER, THE PATIENT REQUIRED A SECOND VENIPUNCTURE TO REPLACE THE DEFECTIVE MIDLINE WITH A FUNCTIONAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789056 ↗
• MalfunctionNov 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED POWERGLIDE SAFETY DID NOT DEPLOY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469668 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING AT THE CATHETER HUB. THE FLUID LEAKED WAS SALINE. THERE WAS NO DELAY IN TREATMENT, NO INTERVENTION NEEDED, AND NO PATIENT HARM. A NEW CATHETER WAS NOT INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467206 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION PROVIDED 10/22/2025: ON (B)(6) 2024, THE PATIENT UNDERWENT MIDLINE PLACEMENT PROCEDURE, USING THE BARD POWERGLIDE MIDLINE CATHTER ON THE LEFT UPPER ARM OF THE PATIENT. THE PATIENT HAD TOLERATED THE PROCEDURE WITHOUT APPARENT COMPLICATIONS OR PROBLEMS. THE CATHETER HAD POSITIVE VENOUS BLOOD RETURN, AND CATHETER FLUSHED WITHOUT RESISTANCE. ON (B)(6) 2024. THE PATIENT WAS DIAGNOSED WITH MRSA SEPSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT THE REMOVAL OF THE INFECTED MIDLINE. LATER ON THE SAME DAY, THE PATIENT UNDERWENT POWERGLIDE MIDLINE PORT PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 23360209 ↗
• MalfunctionSep 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT NEEDLE DID NOT SAFETY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064296 ↗
• InjuryAug 12, 2025Break; Break

  IT WAS REPORTED THAT WHILE PUTTING THE POWER GLIDE IN THE PATIENT IT GOT STUCK. THE ENGAGEMENT SLIDE GOT STUCK UPON WITHDRAWING THE CATHETER TIP REMAIN IN THE PATIENT BUT WAS ABLE TO REMOVE IT. PATIENT DID NOT HAVE TO GO TO THE EMERGENCY ROOM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22783087 ↗
• MalfunctionJun 26, 2025Misassembled; Activation Problem; Misassembled; Activation Problem

  IT WAS REPORTED, THE POWERGLIDE MIDLINE CATHETER WAS MISSING THE SAFETY CLIP. CLIP IS USED IN THE PROCESS WHEN REMOVING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336709 ↗
• InjuryJun 2, 2025Break; Break

  IT WAS REPORTED, NURSE TRYING TO REMOVE THE CATHETER, THE TIP OF THE POWERGLIDE REMAINED INSIDE. PATIENT NEEDS TO BE REFERRED TO IR FOR THE REMOVAL OF THE TIP OF THE CATHETER FROM THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22125225 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "UNKNOWN WHEN IT WAS PLACED BUT NOTED YESTERDAY THAT IT WAS LEAKING AT THE CATHETER HUB. THE DEVICE WAS REMOVED AND A HOLE NOTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931644 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CATHETER HAD A HOLE IN IT. AFTER BEING INSERTED AND THEN FLUSHED, THERE WAS LEAKING NEAR THE BASE OF THE CATHETER. PATIENT WAS STUCK AGAIN WITH NEEDLE FOR CATHETER PLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879900 ↗
• InjuryOct 1, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE STICK WAS EASY AND WENT SMOOTHLY. NEEDLE VERIFIED WITH ULTRASOUND TO BE SOLIDLY IN VAIN. GUIDEWIRE EXTENDED FULLY AND CATHETER ADVANCED UNTIL RESISTANCE MET. ONCE RESISTANCE WAS MET, ATTEMPTED TO RETRACT CATHETER AND MORE RESISTANCE MET. DECIDED TO PULL ENTIRE LINE OUT AND 1.5-2 INCHES OF CATHETER MISSING FROM AROUND NEEDLE. I SAW IT STICKING OUT OF THE ARM AND TRIED TO GRAB IT BUT WENT BACK IN THE SUBQ. WE VERIFIED WITH ULTRASOUND AND X-RAY THAT IT WAS IN THE SUBQ. CATHETER WAS BROKEN OFF IN THE VEIN AND THE SURGEON DID A CUTDOWN TO REMOVE IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20345149 ↗
• MalfunctionAug 22, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER "DURING OUR MIDLINE PROCEDURES WE USE A PRODUCT WHICH CONTAINS THE NEEDLE AS WELL AS GUIDE WIRE IN ONE. EASILY ACCESSED RIGHT BASILIC VEIN AND WALKED NEEDLE IN A FEW CENTIMETERS BEFORE ADVANCING GUIDE WIRE THEN ADVANCING CATHETER. FELT SOME RESISTANCE WHILE ADVANCING CATHETER FROM NEEDLE, USED ULTRASOUND TO FIND NEEDLE TIP AND FOUND IT WAS THROUGH VESSEL WALL AND DOWN BY 1-2CM. HELD ONTO PRONGS OF MIDLINE CATHETER AND RETRACTED REST OF MIDLINE PRODUCT, AS I WAS UNABLE TO RETRACT GUIDEWIRE BACK INTO MIDLINE PRODUCT. CATHETER WITH WINGS AND HUB OF CATHETER INTACT. WING PART OF PRODUCT REMOVED ONLY TO FIND THAT NEEDLE STILL ATTACHED INSIDE CATHETER WITH ABOUT 1-2CM OF END OF NEEDLE EXPOSED. NEEDLE NEEDED TO BE PHYSICALLY REMOVED FROM THE CATHETER." ADDITIONAL INFO 07/30/2024: IT WAS REPORTED BY THE CUSTOMER PATIENT¿S VESSEL WAS DOUBLE WALLED, THIS IS VESSEL INJURY AND PREDISPOSES THE PATIENT TO COMPLICATION. THE CATHETER WAS SUCCESSFULLY PLACED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034062 ↗
• InjuryApr 25, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT TRYING TO PLACE MIDLINE AND COULD TELL WAS NOT IN, PULLED BACK AND GUIDEWIRE GOT STUCK IN PATIENT. THE DR HAD TO PULL IT OUT, GUIDEWIRE LOOKED LIKE IT HAD UNRAVELED. PATIENT SENT TO DIAGNOSTICS TO MAKE SURE THERE WAS NONE OF THE GUIDEWIRE THAT HAD COME LOOSE IN THE PATIENT. PATIENT HARM UNKNOWN AT THIS TIME." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182345 ↗
• MalfunctionApr 18, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT POWERGLIDE NEEDLE DID NOT SAFETY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135288 ↗
• InjurySep 25, 2023Break; Break

  IT WAS REPORTED THAT THE NURSE WAS DISCONTINUING MIDLINE, PATIENT WAS BEING DISCHARGED. THE NURSE REMOVED THE DRESSING AND WHEN SHE PULLED BACK ON THE HUB OF THE MIDLINE IT WAS NOT ATTACHED TO THE CATHETER. THE NURSE STATES THERE WAS VERY LITTLE CATHETER STICKING OUT FROM THE HUB. SHE CALLED CLINICIAN TO BEDSIDE; CLINICIAN COULD NOT VISUALIZE ANY EXTERNAL CATHETER. CLINICIAN PLACED A TOURNIQUET IN THE PATIENT'S AXILLA AND VISUALIZED THE CATHETER WITH ULTRASOUND. THE PATIENT'S ARM IS NOT SWOLLEN, RED OR TENDER. THERE WERE NO INDICATIONS THAT THE CATHETER HAD BECOME DISLODGED PRIOR TO REMOVAL OF MIDLINE. VASCULAR SURGEON CONTACTED AND PLANS FOR SURGERY THIS AFTERNOON TO ATTEMPT REMOVAL. PATIENT WAS TAKEN TO SURGERY AND MIDLINE CATHETER WAS REMOVED. CLINICIAN DOES NOT HAVE A NOTE FROM THE VASCULAR SURGEON STATING EXACTLY HOW IT WAS REMOVED, BUT THE HOSPITALIST TOLD CLINICIAN HE WAS ABLE TO GET IT OUT WITHOUT MAKING ANY NEW INCISION. THE PATIENT WAS THEN DISCHARGED HOME AT 2100 WITH A GAUZE DRESSING OVER THE SITE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17814710 ↗
• MalfunctionJun 27, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT WHILE PRACTICING ON THE VEIN BLOCK IN DIDACTIC CLASS, NURSE THREAD THE CATHETER AND WHEN SHE WENT TO PULL BACK THE DEVICE AND SAFETY THE NEEDLE, THE SAFETY PORTION STAYED ATTACHED TO THE DEVICE AND THE NEEDLE DID NOT SAFETY. ADDITIONAL INFORMATION RECEIVED 06/18/2023: IT WAS REPORTED "DEVICES WERE NOT USED ON A PATIENT, THIS HAPPENED ON THE VEIN BLOCK ON DIDACTIC CLASS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213681 ↗
• MalfunctionJan 19, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, POWERGLIDE WAS PLACED WITHOUT ISSUE, GUIDEWIRE AND CATHETER WERE ADVANCED SMOOTHLY WITHOUT RESISTANCE. AFTER THE SAFETY WAS ACTIVATED, CUSTOMER NOTICED THAT THE GUIDEWIRE TIP WAS HALF ITS NORMAL SIZE. INITIALLY THE CUSTOMER THOUGHT THE WIRE BROKE, BUT AFTER FURTHER EXAMINING THE DEVICE NOTICED THE GUIDEWIRE WAS TANGLED UP INSIDE THE CLEAR HOUSE UNIT OF THE POWERGLIDE. THE ENTIRE WIRE WAS IN THE DEVICE AND NO WIRE WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16209724 ↗
• MalfunctionDec 13, 2022Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "DURING POWERGLIDE (PG) PLACEMENT THE WIRE WOULD NOT ADVANCE INITIALLY. AFTER REPOSITIONING PG THE WIRE AND CATHETER DEPLOYED BUT WHEN THE DEVICE WAS REMOVED THE WIRE WAS NOT VISIBLE. PATIENT RECEIVED XRAY AND BE TAKEN TO IR TO ENSURE WIRE DID NOT SHEAR INTO PATIENT. WIRE WAS NOT OBSERVED IN PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974233 ↗
• InjuryOct 18, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER SHEARED OFF. NURSE MANAGER OF PICC TEAM STATES THAT ON 9-27, 2022, ONE OF HER NURSES WAS PERFORMING A CATHETER EXCHANGE FOR A MIDLINE AND THE CATHETER SHEARED OFF. THE NURSE WAS ABLE TO SEE THE TIP OF THE CATHETER IN THE PATIENT'S "FATTY TISSUE" USING AN ULTRASOUND DEVICE. AN X-RAY WAS PERFORMED THAT VERIFIED THE TIP OF THE CATHETER. SHE REPORTS NO CURRENT PATIENT ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 15629406 ↗
• MalfunctionMay 27, 2022Activation Problem; Activation Problem

  IT WAS REPORTED "WHEN THE CUSTOMER PULLED THE DEVICE OUT THE NEEDLE DID NOT SAFETY. THE NEEDLE AND WIRE CAME ALL THE WAY THROUGH SAFETY DEVICE AND DID NOT ENGAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522774 ↗