Peripheral Catheter Insertion Kit F318107TRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741140518), received between Apr 26, 2018 and Jul 23, 2024 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT, "POWERGLIDE WOULD NOT PUNCTURE THROUGH PATIENTS UPPER ARM BASILIC VEIN. WHEN REMOVED, THE GUIDEWIRE WAS DEPLOYED ABOUT 1/4 CM AND UNABLE TO RETRACT. NEEDLE WENT THROUGH PATIENTS SKIN WITH NO ISSUE BUT MET RESISTANCE ONCE ENTERING THE VEIN. THERE WAS DELAYED VASCULAR ACCESS. IT WAS NOTED THAT THE PATIENT COULDN'T POSITION THEIR ARM CORRECTLY, WHICH CAUSED A VERY AWKWARD ANGLE FOR THE CLINICIAN INSERTING THE DEVICE. THEY MENTIONED THIS COULD HAVE ALTERED THEIR FINGER PLACEMENT, WHICH MAY HAVE LEAD TO PREMATURELY ADVANCING THE GUIDEWIRE. NO SERIOUS INJURY WAS REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812847 ↗
• MalfunctionApr 17, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT THE GUIDE WIRE FRAYED UPON REMOVAL. NO OTHER INFORMATION WAS PROVIDED. 04/12/2024 - TWO DEVICES WERE RETURNED FOR EVALUATION. THE RETURNED DEVICES EXHIBITED BREAKS IN THE GUIDEWIRE. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125235 ↗
• MalfunctionDec 27, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT CUSTOMER WAS CONCERNED THAT POWERGLIDE WIRE WAS STUCK IN PATIENT AS THE WIRE DID NOT SHOW AT THE END OF THE DEVICE AS THEY PERFORMED THE SAFETY ON THE NEEDLE. PATIENT NEEDED TO GET A CHEST XRAY TO CONFIRM THAT A WIRE WASN'T IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED 12/13/2023: THERE WAS NO SERIOUS INJURY TO THE PATIENT OR HEALTHCARE PROVIDER AND NO DELAY OR CHANGE IN TREATMENT. THE PATIENT IS STABLE. THE PROCEDURE FOR MIDLINE PLACEMENT WAS COMPLETED WITHOUT COMPLICATION, UPON RETRACTING NEEDLE, GUIDEWIRE WAS NOT VISIBLE. GUIDEWIRE RETRACTED INTO HOUSING COMPARTMENT OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405232 ↗
• MalfunctionNov 9, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT THE GUIDE WIRE FRAYED UPON REMOVAL. NO OTHER INFORMATION WAS PROVIDED. 04/12/2024 - TWO DEVICES WERE RETURNED FOR EVALUATION. THE RETURNED DEVICES EXHIBITED BREAKS IN THE GUIDEWIRE. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103467 ↗
• MalfunctionJan 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER THAT "THIS WEEK WE HAD ANOTHER PRODUCT MALFUNCTION DURING INSERTION. A DIFFERENT NURSE REPORTS WHEN REMOVING THE GUIDEWIRE AND NEEDLE, THE NEEDLE SEPARATED FROM THE DEVICE AND GUIDEWIRE AND REMAINED IN THE PATIENTS ARM. THE NURSE WAS ABLE TO REMOVE THE NEEDLE SEPARATELY WITHOUT INCIDENT OR HARM TO THE PATIENT. NO REPORTED RESISTANCE OR HARDSHIP WITH INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251116 ↗
• InjuryJan 13, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER VIA PHONE CALL, "THE TIP FELL OFF, THEY DON'T KNOW WHERE THE TIP IS. THEY DON'T KNOW IF IT IS STILL IN THE PATIENT OR NOT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157911 ↗
• InjuryMar 25, 2022Break; Break

  IT WAS REPORTED VIA MEDWATCH "DURING INSERTION OF CATHETER BY USER, MET RESISTANCE. SECOND ATTEMPT MADE AND UNABLE TO THREAD CATHETER INTO VEIN. REMOVED CATHETER AND GUIDE, NOTICED CATHETER TIP MISSING. ULTRASOUND (US) IDENTIFIED TIP WAS LODGED IN THE VEIN. PATIENT DEVELOPED A CLOT AND WAS STARTED ON HEPARIN. PATIENT EVENTUALLY SENT TO INTERVENTIONAL RADIOLOGY (IR) FOR REMOVAL OF RETAINED CATHETER TIP."

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 13905084 ↗
• InjuryJul 7, 2021Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "DEFECTIVE MIDLINE CATHETER BROKE OFF WHILE ATTEMPTING TO INSERT MIDLINE CATHETER TO LEFT UPPER ARM. 2 CM PLASTIC CATHETER TIP LODGED INSIDE THE DERMIS. XRAY VERIFIED, DR. AND PATIENT NOTIFIED." ADD INFO RCVD 06/18/2021: DATE OF OCCURRENCE: (B)(6) 2021. HAS THE CATHETER TIP BEEN REMOVED? IF YES WHAT DATE WAS IT REMOVED: NOT REMOVED, MD RECOMMENDED TO REMOVE IN OUTPATIENT IR. WAS THERE ADDITIONAL MEDICAL INTERVENTION?: REMOVAL SCHEDULED IN OUTPATIENT IR. WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: Foreign Body In Patient

  MAUDE report 12131786 ↗
• InjuryOct 23, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THE RN WAS ATTEMPTING TO PLACE A POWERGLIDE PRO RT AND GOT TO A POINT WHERE SHE THOUGHT SHE WAS IN THE VEIN. SHE ADVANCED THE GUIDEWIRE AND IT FLOWED RELATIVELY SMOOTHLY. WHEN SHE WENT TO ADVANCE THE CATHETER, IT WOULDN¿T ADVANCE. SHE PULLED THE CATHETER BACK AND THEN TRIED TO RETRACT THE WIRE AND IT SHEARED. SHE STOPPED PULLING IT BACK AND SENT THE PATIENT TO INTERVENTIONAL RADIOLOGY TO GET IT REMOVED. THE MD PULLED OUT THE FULL DEVICE AND WIRE AND THE SHEARING WAS THEN OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225521 ↗
• MalfunctionOct 15, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT "THE GUIDEWIRE WAS CHECKED PRIOR TO DEPLOYMENT. NORMAL ACCESS STEPS TAKEN, VENIPUNCTURE MADE. ADVANCED GUIDEWIRE, NO RESISTANCE. ADVANCED CATHETER- MET POSITIVE RESISTANCE, SO RETRACTED THE CATHETER BY PULLING BACK ON THE WINGS AT THAT POINT . ATTEMPTED TO RETRACT GW AND MET POSITIVE RESISTANCE. PATIENT COMPLAINED OF PAIN. ON PALPATION OVER SITE FELT LUMPY. PULLED DEVICE OUT UNDER FLUOROSCOPY AND FRAYED PGLIDE WIRE NOTED. PATIENT DID NOT EXPERIENCE ANY MORE COMPLAINTS OR ISSUES AFTER DEVICE REMOVED. X-RAY NOTED ALL DEVICE REMNANTS REMOVED. RAPID RESPONSE NOTED."

  Patient problems: Pain

  MAUDE report 9195149 ↗
• MalfunctionJul 23, 2019Unraveled Material

  IT WAS REPORTED THAT THE GUIDE WIRE AND CATHETER THREADED EASILY. IT WAS STATED THAT WHEN THE CLINICIAN WENT TO PULL BACK ON THE HOUSING AFTER INSERTION THE GUIDE WIRE HAD UNRAVELED AND WAS STILL IN THE CATHETER WHICH WAS IN THE PATIENT, BUT ALSO STILL ATTACHED TO THE HOUSING. THE CLINICIAN PULL THE CATHETER OUT COMPLETELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8818618 ↗
• MalfunctionJun 6, 2019Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POWERGLIDE WAS PLACED ON 4/25. LINE WAS 18 DAYS OLD. IN THE AM, NURSE WENT TO FLUSH THE LINE AND NOTED IT SQUIRTED ALL OVER. IT WAS STATED THE NURSE LOOKED CLOSER AND THE HUB (GREEN) HAD DISCONNECTED FROM THE TUBING. THE TUBING WAS STICKING OUT OF THE PT ABOUT 1CM. NURSE WAS ABLE TO GRAB THE CATHETER AND REMOVE IT COMPLETELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675754 ↗
• MalfunctionSep 28, 2018Retraction Problem

  IT WAS REPORTED THAT THE NURSE PLACED DEVICE IN UPPER ARM AT A BIFURCATION, DEPLOYED WIRE, THEN ATTEMPTED TO RETRACT WIRE AND IT WOULD NOT RETRACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7919063 ↗
• MalfunctionAug 31, 2018Failure to Advance; Physical Resistance/Sticking

  THE FACILITY REPORTED THE FOLLOWING: "SIZED UP VESSEL, VERY LARGE, UPPER ARM PLACEMENT. ACCESSED VESSEL WITH NO ISSUES, VISUALIZED TIP OF DEVICE DURING INSERTION. CENTERED TIP IN LARGE VESSEL. ADVANCED POWERGLIDE PRO RT WIRE W/O RESISTANCE, PUSHED DEVICE GREEN WINGS FORWARD TO PUSH CATHETER OFF, BUT UNABLE TO ADVANCE WINGS COMPLETELY. FELT A LOT OF RESISTANCE WHEN PUSHING WINGS FORWARD ON DEVICE. RETRACTED WINGS COMPLETELY, THEN TRIED TO RETRACT GW -BUT UNABLE. PULLED EVERYTHING OUT AS ONE UNIT WITH A LOT OF RESISTANCE. WHEN PULLING OUT WIRE UNCOILED AND VERY WIRE THIN AND LOOPED OVER ITSELF IN TISSUE AND BROKE. THEN PULLED OUT REMAINDER GW MANUALLY. NO PT INJURY OR PAIN WAS NOTED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839786 ↗
• MalfunctionAug 16, 2018Connection Problem

  IT WAS REPORTED THAT AFTER DIFFICULT MIDLINE PLACEMENT WITH POWERGLIDE PRO RT, UPON REMOVING THE BLOOD STOPPER, RN PULLED BACK AND BLOOD THAT HAD COLLECTED IN STOPPER FLUNG INTO EYES. RN WENT AND WASHED EYES THOROUGHLY AND WENT TO EMERGENCY DEPARTMENT FOR BLOOD WORK TO BE CONDUCTED. WAITING BLOOD TEST RESULTS ON PATIENT AND RN TO SEE IF THERE WAS EXPOSURE TO ANYTHING SIGNIFICANT. THE SALES REP STATED BLOOD TEST RESULTS ARE NOT AVAILABLE DUE TO PERSONAL NATURE. TO SALES REP'S KNOWLEDGE, RN HAD NO POST EXPOSURE TREATMENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 7791633 ↗
• MalfunctionApr 26, 2018Retraction Problem

  THE TM REPORTED THAT DURING DEMONSTRATION OF THE POWERGLIDE THE GUIDEWIRE WOULD NOT RETRACT AFTER INSERTING THE CATHETER INTO THE VEIN BLOCK. IT WAS STATED THE GUIDEWIRE WAS LODGED INSIDE THE PURPLE HUB (COMPLETELY REMOVED FROM THE HOUSING).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7467268 ↗