Peripheral Catheter Insertion Kit F222088PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741140648), received between Nov 23, 2021 and Apr 14, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Activation Problem

  IT WAS REPORTED THAT A NURSE WENT TO SAFETY A POWERGLIDE AND THE SAFETY CLIP PORTION REMAINED IN THE SEPTUM, CAUSING THE NEEDLE TO COME OUT WITHOUT ANY SAFETY. NO EFFECT ON PLACEMENT OR CLINICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877036 ↗
• MalfunctionMar 16, 2026Material Frayed

  ADDITIONAL INFORMATION RECEIVED ON 17-MAR-2026: I WAS INCORRECT. THE TIP DID NOT BREAK OFF. THEY WERE ABLE TO VERIFY THAT IT WAS FULLY RETRACTED. THE PATIENT DID NOT NEED SURGERY; THE DEVICE WAS REMOVED ALL IN ONE PIECE WITH THE GUIDEWIRE STICKING OUT OF THE NEEDLE. THE NEEDLE HAD SHEARED THROUGH THE CATHETER FOR UNKNOWN REASONS AS THE GUIDEWIRE WAS ONLY DEPLOYED ONCE AND THE CATHETER WAS UNABLE TO BE THREADED. AN X-RAY WAS OBTAINED AS WE WEREN'T SURE IF THERE WAS ANY OF THE GUIDEWIRE MISSING OR NOT, IT APPEARED TO BE AN OUTER SHELL THAT WAS MISSING.

  Patient problems: Pain

  MAUDE report 24606297 ↗
• InjuryDec 6, 2024Break; Break

  IT WAS REPORTED BY MEDWATCH THAT MIDLINE INSERTION WENT WELL INTO VESSEL, THE WIRE WAS DEPLOYED WITH NO RESISTANCE, THE CATHETER WAS INTRODUCED OVER THE GUIDE WIRE WITH NO ISSUES, UPON REMOVING THE FINAL PORTION OF THE DEVICE WHICH SAFETY'S' THE NEEDLE AND PULLS APART FROM THE CATHETER, DEVICE GOT STUCK AND WAS NOT ABLE TO BE REMOVED, THE CATHETER WAS NOTED TO SHEER OFF THE HUB. A TOURNIQUET WAS APPLIED AT THE AXILLA TO PREVENT MIGRATION OF ANY LOOSE CATHETER, THE AREA WAS COVERED WITH STERILE GAUZE AND TEGADERM. UPON REMOVAL IR NOTED THAT THE NEEDLE HAD BROKEN. A MIDLINE WAS PLACED AT IR AS TO NOT DELAY THE DISCHARGE. THE SURGICAL STEEL NEEDLE BROKE IN THE AREA WHERE THERE IS A SMALL NOTCH IN THE SHAFT WHICH EVENTUALLY HELPS SAFETY THE NEEDLE. PATIENT REQUIRED SEDATION AND INTERVENTIONAL RADIOLOGY TO RETRIEVE BROKEN NEEDLE AND PLACE A NEW LINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20870728 ↗
• InjuryOct 27, 2024Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, THE SHAFT OF THE POWERGLIDE NEEDLE BROKE OFF IN THE PATIENT WHILE ATTEMPTING TO REMOVE THE HOUSING ONCE THE VESSEL WAS CANNULATED (GUIDEWIRE AND CATHETER BOTH WERE ADVANCED W/O RESISTANCE). THE DEVICE WAS SECURED, AND THE PATIENT WAS SENT TO THE IR SUITE TO HAVE THE DEVICE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20540998 ↗
• InjuryOct 3, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH "WHILE INSERTING CATHETER BY VASCULAR ACCESS TEAM, THE CATHETER MATERIAL PULLED AWAY FROM THE GUIDEWIRE AND INSERTION DEVICE."

  Patient problems: Foreign Body In Patient

  MAUDE report 20363584 ↗
• InjurySep 5, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT CATHETER SHEARED OFF AND PATIENT WOUND UP GOING TO THE OR FOR REMOVAL OF SHEARED CATHETER. ADDITIONAL INFORMATION RECEIVED ON 21AUG: IT WAS REPORTED THE EVENT OCCURRED DURING A WEEKEND, SO THE VASCULAR SURGERY TEAM WAS CALLED IN AND TOOK THE PT TO THE OPERATING ROOM. IN THE OPERATING ROOM, THEY PERFORMED A CUT-DOWN PROCEDURE AND FOREIGN OBJECT REMOVAL. THE PRODUCT WAS SEVERELY DEFORMED BUT REMOVED IN ITS ENTIRETY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20153841 ↗
• InjuryAug 29, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT RESISTANCE WAS MET WHILE TRYING TO THREAD CATHETER. TWO NURSES ATTEMPTED TO THREAD WITH NO SUCCESS. THEY ATTEMPTED TO REMOVE THE WHOLE DEVICE BUT IT WOULD NOT COME OUT EASILY. ORDERED ULTRASOUND TO SEE THAT THE CATHETER WAS STILL INTACT. THE DEVICE WAS THEN REMOVED, AND THE CATHETER WAS SHEARED OFF. 8/7/2024 ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED X-RAY CONFIRMED BREAK. PATIENT HAD THE CATHETER SURGICALLY REMOVED THE NEXT DAY. PATIENT REPORTED PAIN AND DISCOMFORT WHEN PULLING CATHETER AND DEVICE OUT OF ARM. ALL PIECES REMOVED FROM THE PATIENT.

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 20097263 ↗
• InjuryAug 22, 2023Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT POWERGLIDE CATHETER WAS INSERTED WITH EASE INTO THE PATIENTS VEIN. IT WAS 33% CATHETER TO VEIN RATIO AND FELT NO RESISTANCE. WHEN SHE WHEN TO PULL OUT THE GUIDEWIRE, IT WAS STUCK AND WOULD NOT MOVE. WHEN SHE TRIED AGAIN GENTLY THE CATHETER BROKE OFF AT THE HUB. THE PA CLAMPED THE LINE TO KEEP IT FROM MIGRATING AND THEY SENT THE PATIENT TO IR TO REMOVE THE CATHETER UNDER FLUOROSCOPY. PATIENT RECEIVED A CENTRAL LINE. PATIENT HAD TO HAVE CATHETER REMOVED UNDER FLUOROSCOPY AND HAD TO HAVE A CENTRAL LINE INSERTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17597136 ↗
• InjuryDec 21, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT "CATHETER SHEERED INTO PATIENT (POWERGLIDE 22G, 8CM)" (B)(6) 2022: ADDITIONAL INFORMATION PROVIDED: 22G POWERGLIDE MIDLINE WHILE BEING PLACED IN PATIENT WAS UNABLE TO BE ADVANCED ONCE ACCESS WAS OBTAINED. CATHETER AND WIRE WERE STUCK IN PATIENT. THERE WAS NO REPORTED PATIENT HARM, BUT PATIENT NEEDED INTERVENTION. NO INFECTIOUS DISEASES.

  Patient problems: Foreign Body In Patient

  MAUDE report 16030433 ↗
• InjuryFeb 16, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "WAS PLACING A MIDLINE TO THE RIGHT BASILIC VEIN, VISUALIZED CATHETER IN VEIN, AND THEN ADVANCED THE WIRE WHICH WENT IN EASILY. NEXT ADVANCED THE CATHETER AND MET SOME RESISTANCE AT FIRST BUT THEN WENT IN SMOOTH. TRIED NEXT TO REMOVE GUIDEWIRE WHICH CAME OUT HALFWAY AND STOPPED. THEN TRIED TO REMOVE THE WHOLE CATHETER AND WIRE AND WOULD NOT COME OUT OF SKIN. CALLED THE ADULT CRISIS NURSE TO COME TO SEE IF SHE COULD HELP REMOVE. TRIED TO REINSERT NEEDLE AND THAT CUT THE CATHETER. NOTIFIED THE APN WHO TRIED TO USE SCALPEL AT SITE TO SEE IF THAT WOULD FREE THE CATHETER TO COME OUT BUT UNABLE TO HOLD THE PART OF CATHETER UNDER THE SKIN, SO NEXT CALLED THE SURGEON. SURGEON OPENED THE SKIN ABOUT 3 CM AND REMOVED THE CATHETER WHICH APPEARED TO HAVE ACCORDIONED JUST UNDER THE SKIN."

  Patient problems: Foreign Body In Patient

  MAUDE report 13545928 ↗
• InjuryNov 23, 2021Material Frayed; Material Frayed

  IT WAS REPORTED BY HEALTH PROFESSIONAL "POWERGLIDE GUIDEWIRE DID NOT RETRACT PROPERLY. IT REMAINED IN THE CATHETER WHEN THEY PULLED OUT. THEY SAID THE GUIDEWIRE SNAPPED OFF FROM THE POWERGLIDE BODY AND REMAINED IN THE CATHETER." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12861979 ↗