Peripheral Catheter Insertion Kit F322087TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741140549), received between Oct 13, 2021 and Sep 11, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2023Break; Break

  IT WAS REPORTED THAT A 22G X 8CM POWERGLIDE PRO MIDLINE CATHETER WAS PLACED IN THE LEFT FOREARM USING ULTRASOUND GUIDANCE. ONCE IN THE VEIN WIRE THREADED IN WITH NO ISSUES, ATTEMPTED TO THREAD IN CATHETER AND MET RESISTANCE ABOUT 1/3 OF THE WAY IN. ASSESSED THAT THE NEEDLE WAS STILL IN THE VEIN, BUT CATHETER WOULD NOT ADVANCE THE CATHETER WAS ATTEMPTED TO BE RETRACTED BACK ON THE NEEDLE. RESISTANCE FELT AND HAD TO RETRACT CATHETER, NEEDLE AND GUIDEWIRE ALL TOGETHER WITH MODERATE PRESSURE TO REMOVE DEVICE. ONCE REMOVED, NOTICED THAT 2/3 OF THE CATHETER WAS RETAINED IN THE PATIENT. PATIENT WAS TAKEN TO SURGERY AND A VASCULAR SURGEON REMOVED THE RETAINED CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17726331 ↗
• InjuryAug 9, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT 22G X 8CM POWERGLIDE HAD BROKEN OFF IN A PATIENT. CATHETER WAS IDENTIFIED AND PATIENT IS SET TO HAVE IT REMOVED. ACCORDING TO CUSTOMER THE LINE WAS ATTEMPTED TO BE RE-CANULATED AFTER MEETING RESISTANCE WITH CATHETER ADVANCEMENT PASS THE WIRE. ADDITIONAL INFORMATION RECEIVED ON 27 JULY 2023: THE CATHETER BREAK WAS DISCOVERED DURING DEVICE REMOVAL. 2/3S OF THE CATHETER WAS RETAINED IN THE PATIENT. PATIENT REPORTED PAIN AT THE SITE. X-RAYS WERE TAKEN SHOWING THE RETAINED CATHETER AND AN EXTENSION LOOP FROM ANOTHER IV THAT WAS IN PLACE ABOVE THE CATHETER SITE. PATIENT HAD TO GO TO VASCULAR SURGERY TO HAVE THE DEVICE REMOVED, WHICH WAS SUCCESSFUL. PATIENT DID NOT MISS ANY INFUSIONS DUE TO HAVING ADDITIONAL ACCESS IN PLACE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 17491023 ↗
• InjurySep 20, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "RECEIVED CONSULT FOR MIDLINE PLACEMENT AND INITIALLY AT BEDSIDE AT 2200 ON (B)(6) 2022 FOR PLACEMENT. 1ST ATTEMPT TO LEFT UPPER ARM WOULD NOT ADVANCE IN VEIN ALL THE WAY. 2ND ATTEMPT TO LEFT UPPER ARM ENTERED SMOOTHLY AND WAS FOLLOWED WITH ULTRASOUND GUIDANCE UNTIL IT WAS INSERTED UP TO THE HUB. GUIDEWIRE WAS THEN DEPLOYED AND UPON REMOVAL, BECAME LODGED ((B)(6) 2022 @2240). HEAT INITIALLY APPLIED AND WHEN IT WAS EVIDENT THAT THE CATHETER HAD SHEARED OFF, BEDSIDE RN AND SUBSEQUENTLY THE MD WERE IMMEDIATELY NOTIFIED ((B)(6) 2022 @2250 & 2253). AFTER MULTIPLE XRAYS WERE TAKEN, THE SURGERY TEAM WAS ULTIMATELY CONTACTED AND FIRST ARRIVED AT BEDSIDE @ 0023. AT 0108 ON (B)(6) 2022, MD STARTED PROCEDURE TO REMOVE THE CATHETER AND GUIDEWIRE. AT 0115 ON (B)(6) 2022, GUIDEWIRE AND CATHETER WERE REMOVED BY SURGEON AND PROCEDURE WAS OVER AT 0120."

  Patient problems: Foreign Body In Patient

  MAUDE report 15459005 ↗
• MalfunctionOct 13, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "WHEN INSERTING MIDLINE DEVICE INTO PATIENT, GUIDEWIRE THREADED SMOOTHLY, HOWEVER CATHETER GOT STUCK HALF WAY WHILE ADVANCING, NEEDLE DID NOT RETRACT. ENTIRE DEVICE REMOVED FROM PATIENTS ARM INTACT, VEIN STILL APPEARED INTACT AFTER INSPECTED W/ULTRASOUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627469 ↗