PowerGlide F120100TRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741142673), received between Apr 17, 2019 and Mar 4, 2026 — classified as 8 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Break

  IT WAS REPORTED WE HAD A POWERGLIDE BREAK OFF IN A PATIENT TODAY. WE HAD TO CALL SURGERY. IT WAS ABOUT 4.5CM THAT BROKE OFF. THEY HAD TO CUT A KNICK IN SKIN TO PULL IT OUT. MY NURSE COULD NOT ADVANCE AFTER SHE PULLED OUT GUIDEWIRE AND NEEDLE. SHE WENT TO PULL IT OUT SLOWLY. THERE WAS NO RESISTANCE. IT JUST BROKE OFF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24505646 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  IT WAS REPORTED, HOLE IN THE CATHETER HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290998 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PIECE OF THE ATTACHED MIDLINE CATHETER BROKE AND REMAINED IN THE PATIENT DURING INSERTION PROCESS REQUIRING VASCULAR CONSULT. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 24082853 ↗
• MalfunctionJan 13, 2026Misassembled; Activation Problem

  IT WAS REPORTED THAT AS WE WERE PLACING POWERGLIDES TODAY ONE OF THEM HAD THE SAFETY MECHANISM BROKEN IN IT. WE CHECKED THE WIRE PRIOR TO INSERTION, AND ALL MOVED SMOOTHLY. UPON INSERTING THE NEEDLE AND THEN ADVANCING THE CATHETER INTO THE VEIN, AS THE NURSE RETRACTED THE HOUSING TO SAFETY THE NEEDLE, THE PLASTIC PIECE THAT IS SUPPOSED TO ENCOMPASS THE NEEDLE TIP BROKE INTO TWO PLACES AND NEVER SAFETIED THE NEEDLE. THE BACK PART OF THE PLASTIC STAYED IN THE BACK OUT THE CATHETER HOUSING. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059216 ↗
• InjuryJan 6, 2026Break

  IT WAS REPORTED THAT A PIECE OF THE ATTACHED MIDLINE CATHETER BROKE AND REMAINED IN THE PATIENT DURING INSERTION PROCESS REQUIRING VASCULAR CONSULT. NO FURTHER DETAIL PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23983321 ↗
• 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 AND NO INTERVENTION NEEDED. CATHETER WAS NOT REPLACED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467441 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING AT THE CATHETER HUB. FLUID LEAKED WAS SALINE. THERE WAS NO DELAY IN TREATMENT AND NO INTERVENTION NEEDED. THE CATHETER WAS NOT REPLACED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467437 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER PLACING IN PT ARM; THE LINE ITSELF WAS LEAKING AT THE SKIN ENTRANCE. LINE WAS IN PLACE AND WORKING WELL EXCEPT FOR LEAKING AT THE SITE AFTER FLUSHING WITH SALINE OR PULLING BACK BLOOD. NO INJURY REPORTED. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291594 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER PLACING IN PT ARM; THE LINE ITSELF WAS LEAKING AT THE SKIN ENTRANCE. LINE WAS IN PLACE AND WORKING WELL EXCEPT FOR LEAKING AT THE SITE AFTER FLUSHING WITH SALINE OR PULLING BACK BLOOD. NO INJURY REPORTED. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291563 ↗
• InjuryJun 23, 2025Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "CT OF CHEST WITH CONTRAST WITH AN INCIDENT FINDING: RELATIVELY SIMILAR ROUGHLY 18MM LONG AND THIN WIRE FRAGMENT WITHIN THE RIGHT LOWER LOBE ANTERIOR BASILAR SEGMENTAL PULMONARY ARTERY. PICC LINE PLACED AT BEGINNING OF THE YEAR. PATIENT HAD AN IR PROCEDURE APPROXIMATELY 3 MONTHS LATER - EXCHANGE OF PICC UNDER FLUOROSCOPIC GUIDANCE DONE IN IR. IV THERAPY EVALUATION DUE TO DISCOMFORT WITH RECENTLY EXCHANGED L [LEFT] UPPER ARM DUAL PICC. R [RIGHT] BASILIC POWERGLIDE MIDLINE PLACED." NO ISSUE WAS IDENTIFIED AT THE TIME OF PLACEMENT. UNCLEAR IF THE PATIENT HAS A RETAINED FOREIGN BODY FROM THIS OR A PICC LINE, NO TREATMENT NEEDED, RETAINED FOREIGN BODY LEFT IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22311507 ↗
• MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE ARE CHECKING THE PERMEABILITY OF THE MIDLINE, SO WE ATTEMPT TO ASPIRATE TO VERIFY BLOOD RETURN, BUT WE NOTICE THAT WE ARE ASPIRATING A LOT OF AIR IN THE TUBING AND THE SYRINGE (SEVERAL ML) ON TWO OCCASIONS. NO IRRIGATION WAS DONE AND MIDLINE WAS REMOVED. AFTER REMOVAL, WE PUSH NS TO SEE IF THERE IS A MIDLINE PROBLEM AND LEAK/HOLE IN THE MIDLINE ON THE MIDLINE TUBE NEAR THE PINK BASE (ON THE TRANSPARENT CATHETER PART THAT MEASURES 10 CM AND SHOULD BE WATERTIGHT)." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137589 ↗
• MalfunctionMay 1, 2025Difficult to Insert; Failure to Infuse; Material Deformation; Difficult to Insert; Failure to Infuse; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE IV TEAM CALLED BY PRIMARY RN TO PLACE IV ON PATIENT. ATTEMPTED TO PLACED 20G 10CM POWERGLIDE (LOT REJZ0320). WAS ABLE TO CANNULATE VESSEL WITHOUT ISSUE AND DEPLOY GUIDEWIRE WITHOUT RESISTANCE. THIS NURSE WAS ABLE TO DEPLOY CATHETER AND WAS ABLE TO HUB THE DEVICE AGAINST THE PATIENT'S SKIN. NEXT, WHEN WITHDRAWING NEEDLE AND GUIDEWIRE FROM CATHETER, I MET A GREAT DEAL OF RESISTANCE. THIS NURSE STOPPED AND IMMEDIATELY REMOVED THE ENTIRE APPARATUS FROM THE PATIENT'S ARM. GUIDEWIRE PRESENT AND CATHETER INTACT. THIS NURSE VISUALLY CONFIRMED PRESENCE OF PURPLE CATHETER TIP. ONCE DEVICE WAS REMOVED FROM PATIENT, THIS NURSE PULLED THE CATHETER FROM THE NEEDLE/GUIDEWIRE APPARATUS. I WAS ABLE TO DEPLOY THE SAFETY DEVICE AT THAT TIME. AFTER I HAD THE TWO PIECES APART, I ATTEMPTED TO FLUSH THE IV CATHETER, VERY LITTLE FLOW, NOT CONSISTENT WITH EXPECTED FLOW THROUGH A 20G CATHETER WAS NOTED. PRIMARY NURSE NOTIFIED OF SAME. WE ARE NOT AWARE OF ANY HARM CAUSED TO THE PATIENT AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943516 ↗
• MalfunctionApr 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH WHEN INSERTING POWERGLIDE CATHETER IN PATIENT, IT WAS DISCOVERED TO BE FAULTY. AT THE POINT OF CONNECTING FOR THE CATHETER AND HUB, IT WAS LEAKING CAUSING FLUID/AIR TO BE PULLED INTO THE VESSEL. THIS CATHETER WAS REMOVED, AND A NEW INSERTION WAS COMPLETED WITH SUCCESS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762771 ↗
• MalfunctionMar 14, 2025Difficult to Insert; Activation Problem; Difficult to Insert; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT WHILE ATTEMPTING TO PLACE A MIDLINE, THE NURSE ADVANCED THE GUIDEWIRE WITH NO ISSUE. THE NURSE ATTEMPTED TO ADVANCE THE CATHETER AND THERE WAS RESISTANCE. THE NURSE STOPPED AND ATTEMPTED TO WITHDRAW THE GUIDEWIRE AND WAS UNABLE TO. THE NURSE REMOVED THE ENTIRE MIDLINE WITH GUIDEWIRE FROM THE PATIENT. WITH THE MIDLINE REMOVED FROM THE PATIENT THE NURSE COULD NOT ADVANCE OR RETRACT THE GUIDEWIRE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607510 ↗
• MalfunctionMar 5, 2025Improper or Incorrect Procedure or Method; Defective Component; Improper or Incorrect Procedure or Method; Defective Component

  IT WAS REPORTED THAT THE NURSE HAD NO DIFFICULTY FINDING THE VEIN AND INSERTING THE NEEDLE. ONCE RESISTANCE WAS NOTED AFTER THREADING THE WIRE AND BEGINNING TO ADVANCE THE CATHETER OVER THE WIRE, THE NURSE IMMEDIATELY ATTEMPTED TO REMOVE THE ENTIRE DEVICE WHICH WAS THE CATHETER AND NEEDLE ALL AT ONCE. MUCH RESISTANCE WAS NOTED AT ATTEMPT TO REMOVE DEVICE, BUT AFTER MORE EFFORT WAS APPLIED, THE ENTIRE DEVICE WAS REMOVED WITHOUT ANY PART OF THE CATHETER LEFT IN THE PATIENT. ONCE REMOVED AND EXAMINED, THE CATHETER HAD BEEN SHEARED BY THE NEEDLE, BUT DID NOT BREAK OFF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532164 ↗
• MalfunctionJan 31, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, POWERGLIDE NEEDLE AND CATHETER WERE INSERTED INTO PATIENT, WHEN RN WAS RETRACTING DEVICE THE NEEDLE DID NOT SAFETY / NEEDLETIP EXPOSED. THERE WERE NO COMPLICATIONS TO EITHER THE PATIENT OR THE CLINICIAN. THE NEEDLE GUARD DIDN'T ENGAGE, OR COME OUT OF THE HANDLE AT ALL, BUT NOTICED IT ONCE NURSE WITHDREW IT FROM THE PATIENT SO THERE WERE NO ILL EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283477 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT NURSE PLACED A POWERGLIDE ON A PATIENT AND RIGHT AFTER INSERTION NOTED THAT IT WAS LEAKING AT THE INSERTION SITE WITH FLUSHING. NURSE REMOVED THE POWERGLIDE AND NOTICED IT HAD A PINHOLE IN THE CATHETER RIGHT AT THE HUB. NO HARM WAS DONE TO THE PATIENT AND NO NEGATIVE OUTCOME CAME OF THE EVENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036248 ↗
• InjuryOct 4, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT 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. THEY SAW IT STICKING OUT OF THE ARM AND TRIED TO GRAB IT, BUT WENT BACK IN THE SUBQ AND VERIFIED WITH ULTRASOUND AND X-RAY THAT IT WAS IN THE SUBQ. THIS FILE IS FOR THE FIRST OF TWO OCCURRENCES. ADDITIONAL INFORMATION: THE CATHETER WAS LEFT IN THE PATIENT'S SUBQ TISSUE OF THE PATIENTS' ARMS AND THE PHYSICIAN OPTED NOT TO INTERVENE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20371184 ↗
• MalfunctionOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED UPON INSERTION, VASCULAR ACCESS RN NOTED LEAKAGE FROM THE BASE OF THE CATHETER AND HAD TO REMOVE IT AND PLACE ANOTHER MIDLINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348678 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE MIDLINE CATHETER DEFECTIVE. UPON INSERTION NOTED LEAKAGE FROM THE BASE OF THE CATHETER. HAD TO REMOVE FAULTY LINE AND REATTEMPT WITH NEW SET UP. VASCULAR ACCESS RN PLACED THE MIDLINE BUT HAD TO REMOVE AND PLACE ANOTHER MIDLINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306703 ↗
• MalfunctionSep 19, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY CUSTOMER THAT NEEDLE DIDNT FEEL LIKE IT WOULD ADVANCE AND HE HAD TROUBLE GETTING GUIDEWIRE OUT. ADDITIONAL INFORMATION RECEIVED ON 30 AUG. I DO NOT HAVE AN EXACT DATE, IT WAS USED WITHIN THE LAST 2 WEEKS. THERE WAS NOT ANY HARM OR IMPACT ON THE PATIENT. THE NEEDLE/CATHETER WAS REMOVED WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258537 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE POWERGLIDE CAME APART FROM THE HUB. ADDITIONAL INFORMATION RECEIVED ON 08/05/2024: IT WAS REPORTED THERE WAS A HOLE IN THE CATHETER AT HUB, BLEEDING IMMEDIATELY AT INSERTION AND HAD TO BE REPLACED WITHIN HOURS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20065610 ↗
• MalfunctionJul 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN INCIDENT THIS WEEK WITH A MIDLINE PRODUCT THAT AFFECTED THE PATIENT (THE LINE WAS KNOTTED). ADDITIONAL INFORMATION 06/14/2024: MIDLINE WAS INSERTED INTO A MALE PATIENT RT UPPER ARM. INSERTION WENT SMOOTHLY. FELT SLIGHTLY GRAINY AT THE VERY END OF SLIDING THE CATHETER OFF ONTO THE GUIDE WIRE. SHARP REMOVED EASILY. NO BLOOD BACK THROUGH CATHETER WHEN ATTEMPTED TO DRAW BACK THROUGH 10ML SYRINGE. ATTEMPTED TO WITHDRAW MIDLINE CATHETER OUT OF PATIENT ARM. CATHETER WAS EXTREMELY STIFF TO REMOVE ALMOST AS IF IT WAS CAUGHT ON SOMETHING. THE CATHETER WAS ABLE TO SLOWLY BE REMOVED USING FIRM BACKWARD FORCE. NEAR THE VERY END OF REMOVAL OF CATHETER FROM PATIENT ARM IS WAS VERY PAINFUL FOR PATIENT. MIDLINE CATHETER WAS REMOVED INTACT BUT HAD A TIGHT KNOT NOTED IN THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 19657351 ↗
• MalfunctionMay 9, 2024Difficult to Insert; Improper or Incorrect Procedure or Method; Difficult to Insert; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE ENCLOSED GUIDEWIRE WAS BENT/CURVED ON EXTENDING PRIOR TO ADVANCING THE CATHETER. ONE PATIENT WAS COMPLAINING OF DISCOMFORT WITH THE DEVISE AFTER EXTENDING THE GUIDE WIRE AND STARTED TO ADVANCE THE CATHETER. THE PATIENT WAS UNHARMED AND HAD NO DISCOMFORT AFTER REMOVAL OF THE DEVISE. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Discomfort

  MAUDE report 19281945 ↗
• MalfunctionMay 9, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE ENCLOSED GUIDEWIRE WAS BENT/CURVED ON EXTENDING PRIOR TO ADVANCING THE CATHETER. ONE PATIENT WAS COMPLAINING OF DISCOMFORT WITH THE DEVISE AFTER EXTENDING THE GUIDE WIRE AND STARTED TO ADVANCE THE CATHETER. THE PATIENT WAS UNHARMED AND HAD NO DISCOMFORT AFTER REMOVAL OF THE DEVISE. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Discomfort

  MAUDE report 19281944 ↗