Peripheral Catheter Insertion Kit F320087TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741140525), received between Feb 28, 2018 and Sep 28, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Break; Break

  IT WAS REPORTED THAT POWERGLIDE PRO RT MIDLINE CATHETER WAS SHEARED OFF DURING AN INSERTION ATTEMPT DURING TRAINING. 5.5CM OF CATHETER WAS LEFT WITHIN THE PATIENT¿S ARM. MD NOTIFIED X-RAY PERFORMED IDENTIFIED CATHETER IN TISSUES, NOT VASCULAR, GENERAL SURGERY CONSULTED FOR REMOVAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17839457 ↗
• InjuryApr 15, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "POWERGLIDE CATHETER REMOVED BY CUSTOMER AND 5.5CM OF THE CATHETER BROKE OFF AT A KINKED SIGHT INTO THE PATIENT. PATIENT CURRENTLY HAS 5.5CM OF CATHETER INSIDE OF THEM. THEY ARE ORDERING A DOPPLER TO FIND OUT WHERE THE CATHETER IS. IF THE PIECE IS NOT IN THE VEIN AND IN THE SOFT TISSUE, THEY WILL LEAVE IT." ADDITIONAL INFORMATION RECEIVED 04/01/2022 PATIENT WAS ADMITTED FOR ETOH INTOXICATION. PATIENT WAS A KNOWN DIFFICULT IV STICK WHO REQUIRED US GUIDED IVS OR MIDLINE DURING MULTIPLE PAST ADMISSIONS. "I WAS ATTEMPTING TO A PLACE THIS MIDLINE IN RIGHT BRACHIAL VEIN IN UPPER ARM USING ULTRASOUND. THE TIP OF NEEDLE WAS VISUALIZED WITH FLASH BACK AND GUIDEWIRE WAS DEPLOYED. THE CATHETER WAS THEN ADVANCED. I, HOWEVER, COULD NOT FLUSH OR ASPIRATE BLOOD. I BEGAN TO WITHDRAW THE CATHETER AS I PRESUMED THAT IT HAD KINKED. AS I WAS DOING SO THE CATHETER BROKE AT 2.5CM. THERE REMAINED 5.5CM OF IT IN RIGHT ARM. MY IMMEDIATE US IMAGES DID NOT SHOW THE CATHETER INSIDE THE LUMEN OF BRACHIAL VEIN BUT DID SHOW THE RETAINED CATHETER IN THE SOFT TISSUE. PATIENT¿S TEAM RESIDENT AND INTERVENTIONAL RADIOLOGIST WERE IMMEDIATELY INFORMED. THERE WAS NO BLEEDING, SWELLING, OR COMPLAINTS OF P

  Patient problems: Foreign Body In Patient

  MAUDE report 14117557 ↗
• InjuryJun 3, 2019Break; Detachment of Device or Device Component; Noise, Audible

  MIDLINE CATHETER INSERTED IN THE RIGHT CEPHALIC VESSEL UNDER ULTRASOUND GUIDANCE. VESSEL ACCESSED AND GUIDEWIRE ADVANCED WITHOUT RESISTANCE. AS THE CATHETER WAS ADVANCING, RESISTANCE NOTED AND CATHETER WAS PULLED BACK AND A POPPING SOUND WAS HEARD. CATHETER WAS PULLED OUT AND NOTED THAT THE WIRE WAS SHEARED AND NOT INTACT. STAT X-RAY REVEALED A 4 CM LINEAR METAL OBJECT WITHIN THE ANTEROLATERAL ARM. PT WAS TRANSPORTED TO DIAGNOSTIC IMAGING FOR RETRIEVAL OF THE WIRE FOREIGN BODY. RETRIEVAL WAS SUCCESSFUL WITH NO HARM TO THE PT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8666214 ↗
• InjuryMay 31, 2019Break; Entrapment of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  IT WAS REPORTED RN USED THE ULTRASOUND TO CONFIRM CORRECT PLACEMENT OF POWERGLIDE NEEDLE TIP IN PATIENT¿S RIGHT UPPER ARM. WHEN SHE DROPPED THE ULTRASOUND PROBE, SHE WAS ABLE TO DEPLOY THE GUIDEWIRE SMOOTHLY. AFTER FEELING RESISTANCE WHEN TRYING TO DEPLOY THE CATHETER, RN THEN PROCEEDED TO PULL THE CATHETER BACK TOWARD THE DEVICE WHEN SHE FELT AND HEARD A POP. AFTER PULLING THE ENTIRE DEVICE OUT, THE CATHETER WAS SHEERED TOWARDS THE END AND THE GUIDEWIRE WAS NO LONGER ATTACHED TO THE POWERGLIDE. THE TOURNIQUET WAS LEFT ON PATIENT¿S ARM AND THE GUIDEWIRE WAS CONFIRMED IN PATIENTS VEIN WITH XRAY. PATIENT WAS THEN TAKEN TO IR TO HAVE THE GUIDEWIRE SUCCESSFULLY REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8658093 ↗
• InjuryApr 20, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THE INSERTING RN MET SUBCUTANEOUS RESISTANCE WHEN INSERTING MIDLINE BUT KNEW HE WAS GOING THROUGH SCAR TISSUE, SO PERSISTED. IT WAS STATED THE RN STOPPED AND PULLED THE CATHETER OUT, IT WAS NOTED THAT APPROXIMATELY 2CM OF THE TIP OF THE CATHETER WAS MISSING. THE PATIENT WENT FOR A CT AND X-RAY AND IT SHOWED MULTIPLE IMPLANTS AND STENTS IN THE ARM. THE INSERTING NURSE STATED THAT HE MAY HAVE SHEERED THE CATHETER ON AN IMPLANT OR STENT IN THE PATIENT'S ARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 7447201 ↗
• MalfunctionFeb 28, 2018Kinked; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING INSERTION, TENTING UNDER THE SKIN WAS OBSERVED DUE TO THE CATHETER'S FAILURE TO THREAD AND KINKING. UPON REMOVAL THE GUIDEWIRE WAS NOTED AS BENT AND THE CATHETER TIP DID NOT LOOK INTACT. WHEN THE CATHETER TIP WAS COMPARED WITH A SIMILAR CATHETER TIP, APPROXIMATELY 2 CM OF CATHETER WAS UNACCOUNTED FOR. PATIENT DID NOT EXHIBIT ANY SIGNS OF DISTRESS AT THAT TIME. FOREIGN BODY ULTRASOUND WAS ORDERED FOR LEFT ARM; NO ULTRASOUND RESULTS REPORTED AT THIS TIME.

  Patient problems: No Information

  MAUDE report 7303155 ↗