Peripheral Catheter Insertion Kit F320107TRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741140532), received between Nov 14, 2019 and May 5, 2026 — classified as 5 injuries, 9 malfunctions.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Activation Problem

  IT WAS REPORTED THE NEEDLE TIP SAFETY MECHANISM DID NOT DEPLOY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086825 ↗
• MalfunctionApr 24, 2026Activation Problem

  IT WAS REPORTED THAT ON FRIDAY, MARCH 27, WE ENCOUNTERED AN ISSUE WITH THE POWERGLIDE PRO CATHETER. UPON WITHDRAWAL OF THE NEEDLE/GUIDEWIRE FROM THE PATIENT, THE NEEDLE TIP SAFETY MECHANISM DID NOT DEPLOY. USUALLY, THERE IS A LOCKING CHAMBER THAT DEPLOYS TO COVER THE NEEDLE TIP. NO PATIENT HARM OCCURRED IN THIS CASE. HOWEVER, THIS LED TO AN EXPOSED NEEDLE TIP WHEN SEPARATING THE NEEDLE FROM THE IV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981899 ↗
• MalfunctionAug 25, 2025Material Frayed; Material Frayed

  IT WAS REPORTED; NURSE WAS ATTEMPTING TO PLACE A MIDLINE AND THE GUIDEWIRE SEEMED TO HAVE SOME SORT OF DEFECT. IT WAS NOT ADVANCING PROPERLY AND WHEN THEY ATTEMPTED TO REMOVE IT, THE GUIDEWIRE BROKE OFF IN THE PATIENT. LUCKILY, ENOUGH OF IT WAS PROTRUDING FROM THE SKIN THAT THEY WERE ABLE TO PULL IT OUT MANUALLY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887528 ↗
• InjuryJun 20, 2025Break; Break

  IT WAS REPORTED UPON INSERTION THE CLINICIAN CONFIRMED HE WAS IN THE VESSEL AND STATES THE GUIDEWIRE DEPLOYED WITH NO RESISTANCE. UPON DEPLOYING THE CATHETER, IT BEGAN SMOOTHLY THEN MET RESISTANCE. THE CLINICIAN ATTEMPTED TO BACK THE DEVICE OUT BUT MET RESISTANCE AGAIN. HE CONTINUED TO REMOVE THE DEVICE AND FOUND THE CATHETER HAD SHEARED AND A PIECE WAS LODGED IN THE VESSEL. VASCULAR WAS CONSULTED AND ABLE TO SURGICALLY RETRIEVE THE REMAINING CATHETER WITH NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22299266 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT VASCULAR ACCESS NURSE PLACED THIS POWERGLIDE CATHETER INSIDE A PATIENT, WHEN THEY FLUSHED THE CATHETER, THERE WAS LEAKAGE OUT FROM A SMALL PERFORATION AT THE JUNCTION BETWEEN THE CATHETER AND CATHETER HUB. THIS RESULTED IN THEM HAVING TO PLACE ANOTHER POWERGLIDE IN THE PATIENT, ANOTHER INSERTION/POKE FOR THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038349 ↗
• MalfunctionSep 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT LEFT ARM ATTEMPT ON A PATIENT WITH DIFFICULT VASCULATURE IN THE BASILIC VEIN. THE GUIDEWIRE WAS EXTENDED ONCE BY THE INSERTER AND THEN REPLACED BACK INTO POSITION PRIOR TO INSERTION. THE PATIENT HAD TORTUOUS VEINS, BUT VASCULAR ACCESS WAS ACHIEVED WITH MODERATE DIFFICULTY. WHEN THE INSERTER DEPLOYED THE CATHETER AND TRIED TO FLUSH THE LINE, FLUID WAS OBSERVED SQUIRTING OUT FROM WHERE THE HUB MEETS THE CATHETER DESPITE BEING FULLY CONNECTED. UNFORTUNATELY, THIS RESULTED IN REMOVING THE DEFECTIVE CATHETER AND HAVING TO POKE THE PATIENT A SECOND TIME. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17752903 ↗
• MalfunctionNov 17, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER VIA MEDWATCH "DESCRIBE THE EVENT OR PROBLEM: PATIENT HAD A POWERGLIDE 20GA IN HIS ARM THAT WAS NO LONGER WORKING, WAS NONFUNCTIONING. REGISTERED NURSE (RN) PULLED OUT THE NON-WORKING POWERGLIDE. RN INSERTED THE NEW POWERGLIDE IN THE SAME VEIN AS THE ONE JUST REMOVED. RN FELT RESISTANCE WHEN ADVANCING THE CATHETER OVER THE NEEDLE AND GUIDE WIRE. RN THEN WITHDREW THE CATHETER, GUIDEWIRE AND NEEDLE FROM THE PATIENT. RN NOTICED THE TIP OF THE CATHETER APPEARED TO BE FRAGMENTED AND THE VERY TIP WAS MISSING. X-RAY DID NOT SHOW THE FRAGMENT IN THE ARM, BUT A CT DEMONSTRATES LINEAR RADIOPAQUE FOREIGN BODY WITHIN THE MID MEDIAL ASPECT OF THE ARM MEASURING ABOUT 9 MM IN LENGTH. THIS IS LOCATED IN THE DEEP SOFT TISSUES IMMEDIATELY ADJACENT TO THE BASILIC VEIN AND IS CONSISTENT WITH RETAINED FRAGMENTED CATHETER. AFTER DISCUSSION WITH VASCULAR SURGEON ABOUT RISKS AND BENEFITS OF BOTH TAKING IT OUT OR LEAVING IT IN, THE PATIENT OPTED TO LEAVE IT IN." THIS REPORT ADDRESSES THE NONFUNCTIONING CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816313 ↗
• InjuryNov 11, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER VIA MEDWATCH "DESCRIBE THE EVENT OR PROBLEM: PATIENT HAD A POWERGLIDE 20GA IN HIS ARM THAT WAS NO LONGER WORKING, WAS NONFUNCTIONING. REGISTERED NURSE (RN) PULLED OUT THE NON-WORKING POWERGLIDE. RN INSERTED THE NEW POWERGLIDE IN THE SAME VEIN AS THE ONE JUST REMOVED. RN FELT RESISTANCE WHEN ADVANCING THE CATHETER OVER THE NEEDLE AND GUIDE WIRE. RN THEN WITHDREW THE CATHETER, GUIDEWIRE AND NEEDLE FROM THE PATIENT. RN NOTICED THE TIP OF THE CATHETER APPEARED TO BE FRAGMENTED AND THE VERY TIP WAS MISSING. X-RAY DID NOT SHOW THE FRAGMENT IN THE ARM, BUT A CT DEMONSTRATES LINEAR RADIOPAQUE FOREIGN BODY WITHIN THE MID MEDIAL ASPECT OF THE ARM MEASURING ABOUT 9 MM IN LENGTH. THIS IS LOCATED IN THE DEEP SOFT TISSUES IMMEDIATELY ADJACENT TO THE BASILIC VEIN AND IS CONSISTENT WITH RETAINED FRAGMENTED CATHETER. AFTER DISCUSSION WITH VASCULAR SURGEON ABOUT RISKS AND BENEFITS OF BOTH TAKING IT OUT OR LEAVING IT IN, THE PATIENT OPTED TO LEAVE IT IN.".

  Patient problems: Foreign Body In Patient

  MAUDE report 15780541 ↗
• MalfunctionSep 16, 2022Activation Problem; Activation Problem

  IT WAS REPORTED "CUSTOMER PLACED POWERGLIDE ON PATIENT, LINE WENT SMOOTHLY DURING INSERTION, BUT WHEN CLINICIAN WENT TO REMOVE THE NEEDLE THE SAFETY MECHANISM DID NOT ENGAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442135 ↗
• InjuryAug 25, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED "DURING INSERTION, ATTEMPTED TO ADVANCE CATHETER OVER THE NEEDLE. WENT TO PULL BACK ON NEEDLE AND FELT RESISTANCE. RN AND PA UNABLE TO MANUALLY REMOVE. PA ADMINISTERED SQ LIDOCAINE TO RELAX THE VESSEL AND WAS ABLE TO REMOVE IT. IT APPEARS INTACT BUT IT LOOKS AS IF THERE IS A BREAK OR BENT INSIDE THE CATHETER. THE CATHETER IS DEFINITELY SHEERED IN THE MIDDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299367 ↗
• MalfunctionDec 14, 2020Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER SHEARED WHEN PLACED, RETRACTED CATHETER AFTER FEELING RESISTANCE UPON ADVANCEMENT. THE NURSE HAS TO PLACE ANOTHER LINE. ADDITIONAL INFO RECEIVED 11/30/2020: "I BELIEVE THAT THIS IS MORE TECHNIQUE RELATED¿[BD REP] REVIEWED AND EDUCATED WITH THE NURSE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11003588 ↗
• MalfunctionFeb 26, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE CATHETER WAS FOUND TO HAVE ¿CRIMPS¿ OR ¿KINKS¿ IN THE TUBING PLACING IT AGAIN AT HIGH RISK FOR FAILURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756721 ↗
• InjuryFeb 20, 2020Break; Break

  IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER, THE CATHETER SHEARED AND THE OTHER PIECE THAT SHEARED REMAINED IN THE PATIENT'S ARM. PATIENT WAS TAKEN FOR XRAY AND CT SCAN SHOWED THAT THE SHEARED PIECE REMAINED IN THE PATIENT'S ARM. PATIENT IS SCHEDULED FOR SURGERY TODAY (B)(6) 2020 TO REMOVE SHEARED PIECE. ON 01/30/2020- ADDITIONAL INFORMATION RECEIVED STATED, "AS RN WAS INSERTING THE POWERGLIDE INTO THE PATIENT'S VEIN. RN RECEIVED BLOOD RETURN, GUIDED THE POWERGLIDE INTO THE VEIN, GUIDE WIRE WAS USED BUT MET WITH RESISTANCE. RN RETRACTED THE GUIDEWIRE, READJUSTED THE POWERGLIDE TO BETTER FLOW IN THE VEIN. GUIDEWIRE WAS PUSHED AGAIN BUT NOT MET WITH RESISTANCE. RN INSERT THE REST OF THE POWERGLIDE INTO THE VEIN. NO RESISTANCE WAS MET DURING THE INSERTION, RN PULLED THE DEVICE FROM PATIENT'S ARM, AS RN PULLED THE DEVICE, THE CATHETER WAS PULLED WITH IT." ON 02/03/2020- ADDITIONAL INFORMATION RECEIVED STATED, " WHILE PERFORMING A ROUTINE INSERTION OF THIS DEVICE, THE STAFF MEMBER ENGAGED THE RELEASE BUTTON THAT WOULD RETRACT THE GUIDEWIRE ASSEMBLY AND LEAVE THE CATHETER IN PLACE IN THE PATIENT. HOWEVER, THIS DEVICE FAILED AND WHEN THE BUTTON WAS PUSHED AND DEVICE WITHDRAWN, TH

  Patient problems: Foreign Body In Patient

  MAUDE report 9732435 ↗
• InjuryNov 14, 2019Break; Break

  IT WAS REPORTED VIA MEDWATCH REPORT, "A MIDLINE WAS INTENDED TO BE PLACED TO CONTINUE IV ANTIBIOTICS WITH HOME INFUSION. THE INITIAL ATTEMPT WAS UNSUCCESSFUL. HOWEVER, WHILE REMOVING THE LINE, THE DISTAL PORTION F THE CATHETER WAS SHEARED AND BECAME TRAPPED UNDER THE SKIN. AN ULTRASOUND CONFIRMED OPAQUE FOREIGN BODY MATERIALS WITHIN THE SOFT TISSUES. APPROX SIZE OF 4 CM. VASCULAR SURGERY WAS NOTIFIED AND EVALUATED THE PATIENT. HE FELT RISK OF EXPLORATION AND REMOVAL OUTWEIGHED THE BENEFIT AND IT WAS RECOMMENDED TO LEAVE THE RETAINED FOREIGN OBJECT."

  Patient problems: Foreign Body In Patient

  MAUDE report 9323341 ↗