Peripheral Catheter Insertion Kit F118108PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00801741140563), received between Apr 26, 2018 and May 13, 2026 — classified as 11 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (10 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Misassembled; Activation Problem

  IT WAS REPORTED THAT NO SAFETY. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162909 ↗
• MalfunctionFeb 27, 2026Activation Problem

  IT WAS REPORTED, THE NEEDLE OF THE POWERGLIDE BECAME DETACHED FROM THE BODY OF THE DEVICE UPON SAFETY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475718 ↗
• MalfunctionFeb 27, 2026Product Quality Problem; Detachment of Device or Device Component

  IT WAS REPORTED, BROKE APART AFTER I THREADED THE CATHETER AND WENT TO PULL THE NEEDLE OUT. PATIENT IS TOTALLY FINE, LINE IS GREAT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470795 ↗
• InjuryFeb 23, 2026Break

  IT WAS REPORTED VIA MEDWATCH THAT PATIENT HAD AN IV (INTRAVENOUS) TEAM CONSULT TO PLACE A PERIPHERAL IV DUE TO DIFFICULT ACCESS. NURSE IV SPECIALIST FOUND LIMITED PERIPHERAL SITES AND RECOMMENDED A MIDLINE CATHETER TO PRESERVE PERIPHERAL VEINS AND REDUCE REPEATED NEEDLESTICKS. IV SPECIALIST ATTEMPTED TO PLACE A 10CM POWERGLIDE MIDLINE CATHETER INTO THE LEFT UPPER ARM. WHILE ADVANCING THE GUIDEWIRE, HE SENSED THE CATHETER CANNULA FOLDING AND REALIZED THE ATTEMPT FAILED. UPON DEVICE REMOVAL, 7CM OF THE CATHETER DEVICE EXTRACTED AND 3CM SHEARED OFF IN THE PATIENT'S SUBCUTANEOUS TISSUE. PATIENT HAD NO COMPLAINTS OF PAIN AND THERE WAS NO CIRCULATORY COMPROMISE TO THE LEFT UPPER EXTREMITY. PHYSICIAN WAS NOTIFIED AND VASCULAR SURGERY WAS CONSULTED FOR EVALUATION. THE CATHETER TIP WAS UNABLE TO BE DEFINITIVELY LOCATED ON BEDSIDE ULTRASOUND OR WITH CT (COMPUTED TOMOGRAPHY) IMAGING. A LEFT HUMERUS X-RAY SHOWED EVIDENCE OF THE FOREIGN BODY. FOUR DAYS LATER, PATIENT UNDERWENT A LEFT UPPER EXTREMITY EXPLORATION AND FOREIGN BODY REMOVAL OF THE CATHETER TIP. THE IV SPECIALIST SUSPECTS THE ERROR MAY HAVE OCCURRED WHEN HE REMOVED THE DEVICE NEEDLE, LEAVING THE FOLDED CATHETER IN PLACE, AND PULLED T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24414382 ↗
• InjuryJan 27, 2026Break

  IT WAS REPORTED THAT DURING AN ATTEMPTED MIDLINE PLACEMENT, DEFORMATION OF THE MIDLINE CATHETER WAS NOTED. UPON TERMINATION OF MIDLINE INSERTION EFFORTS, REMOVAL OF THE DEFORMED MIDLINE RESULTED IN A SHEARING OF THE APPROXIMATE DISTAL 3CM OF THE CATHETER. THIS REQUIRED ESCALATION IN THE FORM OF SURGERY CONSULTATION AND IMAGING. NO FURTHER DETAILS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24192064 ↗
• MalfunctionDec 17, 2025Material Frayed; Product Quality Problem; Material Frayed; Product Quality Problem

  IT WAS REPORTED BY CUSTOMER THAT WINGS FELT WEIRD WENT TO PULL WIRE BACK AND WIRE WOULDN'T COME BACK. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830468 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PROVIDER PLACED A MIDLINE IN A PATIENT AND HAD TO REMOVE IT BECAUSE IT WAS PULLING AIR WHEN DRAWING BLOOD BACK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927901 ↗
• InjuryApr 24, 2025Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE IN HALF WHILE INSIDE PATIENTS VEIN. THE NEEDLE REMAINED INTACT BUT UPON THE NURSE REMOVING THE NEEDLE ONLY HALF OF THE CATHETER REMAINED ON THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21904697 ↗
• MalfunctionMar 13, 2025Activation Problem; Activation Problem

  IT WAS REPORTED WHEN STAFF USED THIS ITEM, THE SAFETY DEVICE DID NOT DEPLOY AFTER USE. ONCE MIDLINE IV IS INSERTED AND THE NEEDLE COMES OUT A SAFETY DEVICE AUTOMATICALLY CLIPS OVER THE NEEDLE TIP PREVENTING ACCIDENTAL STICKS. THIS DID NOT HAPPEN. IT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21601016 ↗
• MalfunctionFeb 19, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE GREEN SAFETY DID NOT COME OUT WHEN THE DEVICE WAS SAFETY. GREEN PIECE WAS DISLODGED INSIDE THE POWERGLIDE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412852 ↗
• MalfunctionSep 28, 2024Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT CLINICIAN HAD A MALFUNCTIONING MIDLINE KIT WHEN HE WENT TO PLACE A LINE ON PATIENT, THE BREAKAWAY SHEATH IS SUPPOSE TO SPLIT IN 3 PIECES AND IT DIDN'T SO HE HAD TO GET A NEW KIT. HE DID NOT SAVE THE PIECES FOR YOU TO SEND BACK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328775 ↗
• MalfunctionAug 30, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT YELLOW SUSTENANCE STAIN ON ITEM. NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107716 ↗
• MalfunctionAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT NURSE INSERTED PG USING THE MASK IN THE KIT AND GOT NASAL AND THROAT IRRITATION. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Sore Throat

  MAUDE report 20044630 ↗
• MalfunctionJul 18, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT POWERGLIDE FAILED TO DEPLOY THE SAFETY DEVICE AFTER INSERTION. THE CATHETER DID DEPLOY BUT THE SAFETY PORTION STAYED IN THE DEVICE SO THE NEEDLE WAS EXPOSED AFTER INSERTION. NO ADVERSE EVENTS OR INJURIES FROM EVENT ARE NOTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771969 ↗
• InjuryNov 21, 2023Break; Break

  IT WAS REPORTED ATTEMPTED ACCESS OF MIDLINE POWER GLIDE PRO MIDLINE CATHETER IN RIGHT UPPER ARM WHILE ADVANCING CATHETER BROKE IN THREE PIECES, TRYING TO REMOVE DEVICE AND CATHETER FROM RIGHT UPPER ARM CATHETER MET RESISTANCE WITH REMOVAL AND BROKE OFF IN PATIENT'S RIGHT UPPER ARM. APPROX. 3.75CM OF CATHETER UNACCOUNTED FOR. CATHETER NOT VISUALIZED VIA ULTRASOUND MACHINE ER TEAM NOTIFIED. NO OTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18187754 ↗
• InjuryJul 20, 2023Break; Break

  IT WAS REPORTED VIA MEDWATCH "THE PATIENT HAD AN 18G RIGHT UPPER ARM MIDLINE (BASILIC VEIN) CATHETER PLACED ON (B)(6) 2023. ON (B)(6) 2023 WHILE AT OUTPATIENT THERAPY TO GET HIS IV ANTIBIOTICS THE LINE WAS NOTED TO BE LEAKING. THE RN PULLED DOWN THE DRESSING AND NOTICED THE CATHETER HUB AND PART OF THE CATHETER HAD BROKEN OFF, LEAVING A PART OF THE CATHETER IN THE PATIENT'S ARM. THE PATIENT WAS TAKEN TO THE ED(EMERGENCY DEPT) AND THEN WENT TO THE OPERATING ROOM FOR A VENOTOMY WHERE THE BROKEN PIECE IN THE PATIENT'S ARM WAS SUCCESSFULLY REMOVED."

  Patient problems: Foreign Body In Patient

  MAUDE report 17364006 ↗
• InjuryJul 12, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE MIDLINE WAS WORKING WELL AFTER PLACEMENT ON (B)(6) 2023. THE PATIENT WAS AN OUTPATIENT COMING IN FOR DAILY INFUSIONS THEREFORE DAILY ASSESSMENT WAS NOT DONE BY THE VAT TEAM BUT BY THE OUT PATIENT NURSES. THE NURSE STATED THAT LAST WEEK HE HAD A KINK IN THE CATHETER THAT PREVENTED IT FROM FLUSHING. THE NURSE BACKED OUT THE CATHETER TO STRAIGHTEN THE KINK. IT WORKED UNTIL (B)(6) 2023 WHEN THE NURSE ATTEMPTED TO FLUSH THE LINE AND THE FLUSH CAME OUT FROM UNDER THE DRESSING. THE DRESSING WAS THEN REMOVED THINKING THE CONNECTION TO THE EXTENSION WAS LOOSE. THE LINE WAS PULLED BACK AGAIN AND ONLY APPROXIMATELY 1 CM OF THE CATHETER WAS ATTACHED TO THE HUB. AN ULTRASOUND WAS USED TO VISUALIZE THE REMAINING CATHETER IN THE VEIN. A TOURNIQUET WAS PLACED TO PREVENT IT FROM DISLODGING ANY FURTHER AND THE PATIENT WAS SENT TO THE ER FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 30-JUN-2023: ON (B)(6) 2023 HE PRESENTED TO THE ED AS A TRAUMA AFTER HE INJURED HIS ELBOW WITH AN ELBOW LACERATION, SENT HOME AND RETURNED ON (B)(6) 2023 WITH INCREASED PAIN TO ELBOW. (B)(6) 2023 IRRIGATION AND DEBRIDEMENT OF LEFT MEDIAL ELBOW ABSCESS AND SEPTIC ARTHRITIS, PLA

  Patient problems: Foreign Body In Patient

  MAUDE report 17312973 ↗
• InjuryJun 23, 2023Break; Fluid/Blood Leak

  THE PATIENT HAD AN 18G RIGHT UPPER ARM MIDLINE (BASILIC VEIN) CATHETER PLACED ON (B)(6) 2023. ON (B)(6) 2023 WHILE AT OUTPATIENT THERAPY TO GET HIS IV ANTIBIOTICS THE LINE WAS NOTED TO BE LEAKING. THE RN PULLED DOWN THE DRESSING AND NOTICED THE CATHETER HUB AND PART OF THE CATHETER HAD BROKEN OFF, LEAVING A PART OF THE CATHETER IN THE PATIENT'S ARM. THE PATIENT WAS TAKEN TO THE ED(EMERGENCY DEPT) AND THEN WENT TO THE OPERATING ROOM FOR A VENOTOMY WHERE THE BROKEN PIECE IN THE PATIENT'S ARM WAS SUCCESSFULLY REMOVED.

  Patient problems: Foreign Body In Patient; Laceration(s)

  MAUDE report 17203755 ↗
• MalfunctionMar 9, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "SAFETY ON POWERGLIDE PRO FAILED TO ENGAGE." CUSTOMER REPORTS THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16510545 ↗
• MalfunctionMar 3, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "PER THE UNIT MANAGER THE DEVICE REACHED THE PATIENT-MIDLINE IV DEVICE THAT THE SAFETY CAP/SHEATH DID NOT DEPLOY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479279 ↗
• MalfunctionMar 2, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "THE INSERTION OF THE CATHETER "FELT FUNKY - WORKED FINE BUT SAFETY DIDN'T DEPLOY - IT'S STILL UP IN THE HOUSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475509 ↗
• MalfunctionFeb 27, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "GUIDEWIRE DID NOT DEPLOY AND WAS FOUND COILED IN THE BACK OF THE DEVICE HANDLE." 02/16/2023 - THE RETURNED SAMPLE EXHIBITED A DAMAGED CATHETER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444130 ↗
• MalfunctionJul 8, 2022Activation Problem; Activation Problem

  IT WAS REPORTED BY RN," WHEN PLACING THE MIDLINE ON (B)(6) 2022 THE SAFETY MECHANISM ON THE BARD MIDLINE FAILED TO STAY IN PLACE PROPERLY. USUALLY ONCE YOU THREAD THE GUIDEWIRE AND THEN SLIDE THE CATHETER OVER TOP, AS YOU ARE PULLING THE NEEDLE OUT IT CATCHES ON A SAFETY MECHANISM TO ENCLOSE THE SHARP. INSTEAD THIS TIME AS I PULLED THE NEEDLE OUT THE SAFETY MECHANISM SLID OFF THE END OF THE NEEDLE AND OVER THE GUIDEWIRE, FALLING ONTO THE BED, LEAVING THE NEEDLE EXPOSED. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962287 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "NURSES ARE SAYING THE WIRE IS SHEARING THE VEIN." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 14734730 ↗
• MalfunctionFeb 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "THE PICC NURSE HAD 5 OF THESE LINES DOUBLE BACK ON HER IN A COURSE OF 2 DAYS." ADDITIONAL INFORMATION RECEIVED "FROM WHAT I GATHERED, THE LINES WOULD CREATE A U UPON INSERTION OR COIL DURING PLACEMENT. SECONDLY, THERE WAS NO PATIENT HARM. " (B)(6) 2022 -ONE USED SAMPLE WAS RETURNED TO REPRESENT THE 5 AFFECTED UNITS. THE RETURNED SAMPLE SHOWED KINK DAMAGE. THE FACILITY REPORTED THE SAME ISSUE OCCURRING ON 5 CATHETERS. THIS REPORT ADDRESSES THE FIFTH DEVICE/NO SAMPLE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536389 ↗