Peripheral Catheter Insertion Kit F318088PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741140655), received between Feb 14, 2018 and Mar 24, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Material Deformation

  IT WAS REPORTED THAT THE CLAMP ON THE EXTENSION TUBING IN THE KIT WAS JAMMED INTO THE TAPE THAT COMES WITH THE DRESSING PACKAGING. THE TUBING WAS SO KINKED THAT EVEN WITH ATTEMPTS TO SMOOTH OUT, IT WOULD NOT GIVE BLOOD RETURN. A SECOND KIT WAS OPENED TO USE NEW TUBING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675624 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, ACCESSED VEIN AND PUSHED BUTTON TO RETRACT NEEDLE AND WHEN SEPARATING CATHETER HUB FROM HOUSING NOTED THAT NEEDLE WAS MISSING. NEEDLE SEPARATED FROM GREEN HOUSING AND WAS LEFT INSIDE CATHETER HUB AND PATIENT. VAT WENT TO REMOVE NEEDLE FROM CATHETER AND MET RESISTANCE, CATHETER WAS PULED BACK UNTIL NEEDLE WAS FREE TO BE REMOVED WITH NO RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473387 ↗
• InjuryApr 26, 2025Break; Break

  IT WAS REPORTED VIS MEDWATCH THAT ULTRASOUND GUIDED POWERGLIDE MIDLINE (18 G 8 CM) INSERTION WAS ATTEMPTED. STERILE PROCEDURE PER PROTOCOL AND NEEDLE TIP SEEN WITHIN VESSEL. GUIDEWIRE DEPLOYED WITHOUT COMPLICATION; HOWEVER, CATHETER WOULD NOT GLIDE OVER WIRE. AFTER SECOND FAILED ATTEMPT OF CATHETER GLIDING OVER GUIDEWIRE, INSERTER DECIDED TO REMOVE ENTIRE MIDLINE CATHETER. NEEDLE REMOVED AND SAFETY DEPLOYED WITHOUT COMPLICATION. UPON REMOVING CATHETER, INSERTER MET RESISTANCE ONCE APPROXIMATELY 6 CM OF CATHETER REMOVED FROM PATIENT'S ARM. CATHETER WAS SECURED TO PATIENT'S ARM WITH TEGADERM AND A CHEST/ARM XRAY WAS COMPLETED. CATHETER AND GUIDEWIRE REMOVED. ADDITIONAL CHEST/ARM XRAY COMPLETED AFTER REMOVAL. GUIDEWIRE APPEARS TO HAVE COME LOSE FROM DEVICE AND CATHETER TIP NOT INTACT. THE CATHETER WAS 7 CM UPON REMOVAL. APPROXIMATELY 1 CM OF RETAINED MIDLINE CATHETER IN PATIENT'S LEFT ARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21915644 ↗
• MalfunctionFeb 2, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER, 'POWERGLIDE MALFUNCTION NOTICED. WHEN REMOVING NEEDLE, NEEDLE STAYED IN VEIN WITH THE CATHETER. THE POWERGLIDE WAS ASSEMBLED INCORRECTLY, NEEDLE RETRACTED HAS BLUNT END NOT BEVELED.'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284564 ↗
• MalfunctionJun 9, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "UPON WHAT APPEARED TO BE A ROUTINE, STRAIGHTFORWARD INSERTION, THE NEEDLE DID NOT SAFETY PROPERLY. NO PATIENT HARM, NO CLINICIAN HARM, CATHETER PLACED SUCCESSFULLY AND FUNCTIONING PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971246 ↗
• InjuryAug 21, 2020Break; Break

  IT WAS REPORTED "PATIENT WAS SENT TO SURGERY THIS MORNING (7/28) AS THERE WAS A POWERGLIDE ON (7/25) THAT "BROKE OFF" INTO PATIENT AND THEY NEEDED TO GET IT OUT. DEVICE WAS THROWN AWAY BUT CATHETER THAT WAS FOUND IN ARM WAS SENT TO PATHOLOGY AFTER SURGERY." PICC WAS PLACED IN RIGHT UPPER ARM AND SECURED WITH STATLOCK.

  Patient problems: Foreign Body In Patient

  MAUDE report 10435991 ↗
• MalfunctionJun 29, 2018Component Missing; Physical Resistance

  IT WAS REPORTED THAT "RN ATTEMPTED TO PLACE POWERGLIDE TO RIGHT CEPHALIC VEIN. THE VEIN WAS ACCESSED WITHOUT DIFFICULTY, WIRE WENT IN SMOOTHLY, CATHETER INSERTED HALFWAY WITH RESISTANCE MET AT THAT POINT. WITHDREW DEVICE FROM CATHETER AND IMMEDIATELY NOTED SMALL WIRE AT THE TIP OF THE DEVICE WAS MISSING. RN IMMEDIATELY REMOVED THE CATHETER AND FLUSHED WITH NORMAL SALINE TO SEE THE WIRE WAS IN THE CATHETER. NO WIRE NOTED. A CALL WAS PLACED TO PHYSICIAN WITH ORDERS RECEIVED FOR STAT CHEST X-RAY AND ULTRASOUND OF RIGHT UPPER EXTREMITY. XRAY AND ULTRASOUND COMPLETED WITH NO ABNORMALITIES AND NO WIRE NOTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650188 ↗
• MalfunctionJun 29, 2018Complete Blockage; Occlusion Within Device

  IT WAS REPORTED THAT CATHETER WAS INSERTED AND SOON THEREAFTER CATHETER WAS CLOGGED, UNUSABLE AND REMOVED. THIS IS WHEN RN NOTED A WIRE IN THE ACTUAL CATHETER, THIS CAUSED THE LINE TO BE OCCLUDED. X-RAY DONE TO MAKE SURE A PIECE WAS WIRE WAS NOT DISLODGED AND GONE INTO PATIENT. NO FOREIGN MATERIAL WAS REPORTED TO BE RETAINED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650186 ↗
• MalfunctionFeb 14, 2018Material Integrity Problem

  IT WAS REPORTED THAT THE NURSE PLACED THE POWERGLIDE PRO, AND UPON REMOVING THE HOUSING, SHE NOTED A 'FISHING LINE' LEFT OUTSIDE OF THE CATHETER. SHE WAS UNABLE TO REMOVE IT. NURSE STATES "THE ENTIRE CATHETER WAS REMOVED, AND DUE TO THE PATIENT'S POOR VEINS, ANOTHER PLACEMENT WAS NOT ATTEMPTED." NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7271058 ↗