Peripheral Catheter Insertion Kit F218108PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741140617), received between Oct 19, 2018 and Aug 27, 2025 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Break; Break

  IT WAS REPORTED THE CATHETER BROKE INSIDE THE PATIENT, DISCONNECTED FROM THE HUB. PATIENT HAD TO BE TRANSFERRED FOR DIAGNOSTIC AND SURGICAL INTERVENTION. THE INTERVENTION OCCURRED (B)(6) 2025. THE DEVICE WAS SUCCESSFULLY REMOVED AT ANOTHER FACILITY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22903053 ↗
• MalfunctionJun 30, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED MIDLINE CATHETER WAS REMOVED. AFTER REMOVAL IT WAS OBSERVED THAT A PIECE OF THE TIP WAS MISSING. ADDITIONAL INFORMATION: NO IMAGING WAS DONE DURING THAT VISIT. AN X-RAY WAS PERFORMED 5 DAYS LATER, WHICH SHOWED NO RADIOPAQUE FOREIGN BODY. PATIENT HAS NO SYMPTOMS RELATED TO A POTENTIALLY RETAINED CATHETER TIP. THERE WAS NO NOTED DIFFICULTY DURING THE INSERTION OF THE CATHETER INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359878 ↗
• MalfunctionJun 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, A PATIENT WHO HAD A MIDLINE CATHETER INSERTED ON (B)(6) 2025, BY A CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA). THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT THE FOLLOWING DAY BECAUSE THE HOME HEALTH TEAM WAS UNABLE TO FLUSH THE LINE. WHILE IN THE EMERGENCY DEPARTMENT, THE STAFF ALSO HAD TROUBLE FLUSHING THE CATHETER. A CRNA WAS CONSULTED AND ATTEMPTED TO FLUSH THE CATHETER USING CATHFLO. HE ADVISED WAITING TWO HOURS BEFORE MAKING ANOTHER ATTEMPT. TWO HOURS LATER, WHEN FLUSHING WAS ATTEMPTED AGAIN, RESISTANCE WAS STILL ENCOUNTERED. THE CRNA WAS CALLED BACK AND SUBSEQUENTLY REPLACED THE MIDLINE CATHETER. UPON REMOVAL, IT WAS OBSERVED THAT THE CATHETER HAD TWO KINKS. ADDITIONAL INFORMATION PROVIDED 19-JUN-2025: THERE WAS NO DIFFICULTY WITH THE INITIAL INSERTION OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352665 ↗
• InjuryJun 25, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER POWERGLIDE CATHETER BROKE OFF IN A PATIENT, PORTION OF CATHETER WITHIN PATIENT VEIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22332174 ↗
• MalfunctionNov 21, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THE PATIENT'S LINE WAS PLACED(B)(6)2023 AND OVER THE WEEKEND WHEN THE PATIENT CAME IN FOR HIS INFUSION, HIS POWERGLIDE WAS LEAKING WHERE THE CATHETER MEETS THE HUB. I LOOKED AT THE CATHETER ITSELF AND THE HUB WAS STARTING TO BECOME DISCONNECTED. THE NURSES DID PULL THE LINE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185955 ↗
• MalfunctionNov 15, 2023Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT PLACING THE DEVICE AND THE CATHETER DID NOT DEPLOY. SO, SHE PULLED THE ENTIRE DEVICE BACK AND IT FELT STUCK. THEY DID TAKE THE DEVICE APART TO MAKE SURE THE WHOLE WIRE WAS THERE. NO OTHER INFORMATION PROVIDED.

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

  MAUDE report 18145761 ↗
• MalfunctionMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "EXTENSION SET IS LEAKING, HAD TO CLEAN UP MESS AND REPLACE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004394 ↗
• MalfunctionFeb 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "UPON DEPLOYMENT AND RETRACTION IT GOT STUCK. THEN IT DIDN'T COME APART. RN HAD TO PLACE NEW POWERGLIDE AND IT WORKED." ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED BY THE CUSTOMER ¿POWERGLIDE WAS BEING PLACED, UNEVENTFUL ACCESS OBTAINED INTO VESSEL, TIP WALKED A BIT AND WIRE ADVANCED AS USUAL TO GAIN VESSEL PURCHASE BEFORE DEPLOYMENT OF CATHETER, CATHETER SEEMED TO DEPLOY AS USUAL, UPON RETRACTION OF NEEDLE FROM THE CATHETER THERE WAS A HANG UP OR RESISTANCE ON REMOVAL OF NEEDLE AND POWERGLIDE HOUSING, HAD TO PULL BACK A BIT TO GET CATHETER OFF AND GIVEN THE DIFFICULTY THE DECISION WAS MADE TO DC CATHETER AS I QUESTIONED IF IT WAS INTACT, THE CATHETER WAS INTACT. THE TEAL WINGS FOR THE SYSTEM REMAINED ATTACHED TO THE NEEDLE AND POWERGLIDE HOUSING INSTEAD OF THE CATHETER AS USUAL TOO.¿ THERE WAS NO PATIENT HARM, JUST THAT THE PROCEDURE HAD TO BE REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359668 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "CALLER STATES THEY HAVE A PATIENT WHO HAS HAD SEVERAL POWERGLIDE PRO MIDLINES PLACED OVER THE LAST FEW DAYS. PATIENT CONTINUES TO COMPLAIN OF PAIN WHEN FLUSHING. CALLER STATES THE VEIN IS THE CORRECT SIZE AND PLACEMENT IS ACCURATE. CALLER ASKING IF THE PATIENT COULD BE HAVING A REACTION THE MATERIAL IN THE MIDLINE. CALLER STATES THEY HAVE DISCONTINUED THE MIDLINE AND POSSIBLY PLACING A POWERPICC SOLO." A SPECIFIC NUMBER OF DEVICES PLACED WAS NOT PROVIDED.

  Patient problems: Pain

  MAUDE report 16216939 ↗
• InjuryJul 29, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER "POWERGLIDE PRO COULD NOT BE REMOVED FROM THE PATIENT RADIOLOGY TEAM WAS ABLE TO REMOVE FROM THE PATIENT AND THE PATIENT¿S BEDSIDE."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130289 ↗
• InjuryMar 19, 2022Break; Break

  IT WAS REPORTED "FLOOR RN WAS DCING PG CATHETER AND WHEN TOOK DRESSING OFF ARM THERE WAS NO CATHETER ATTACHED TO THE HUB. COULD NOT SEE THE CATHETER UNDER THE SKIN BUT PATIENT SAID WAS TENDER. DID AN X-RAY INSIDE THE ROOM AND CATHETER WAS EVIDENT IN THE ARM. PLACEMENT WAS R UPPER ARM BRACHIAL. DID ULTRASOUND OF THE AREA AND THERE WAS A CLOT. DECISION WAS TO SURGICALLY REMOVE AND THAT IS SCHEDULED FOR TODAY MONDAY THE (B)(6). CATHETER WAS LOCATED RIGHT WHERE INSERTION SITE WAS. THE PG WAS PUT IN BY PICC TEAM.." "ON FRIDAY WE HAD A PATIENT WHOSE POWERGLIDE WAS REMOVED AND THE CATHETER WAS RETAINED. WE HAVE SAVED THE PIECE THAT CAME OUT, AND THE PATIENT IS GOING TO IR TODAY TO TRY TO REMOVE THE RETAINED CATHETER." ADDITIONAL INFO. RECEIVED: WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME: PATIENT HAD TO UNDERGO ULTRASOUND AND THEN SURGICAL PROCEDURE FOR REMOVAL, HOSPITALIZATION WAS EXTENDED (PATIENT WAS IN PROCESS OF BEING DISCHARGED WHEN RETAINED CATHETER FRAGMENT DISCOVERED) AND A THROMBUS CENTERED AROUND THE CATHETER IN THE PROXIMAL AND MID SEGMENTS OF THE DEEP BRACHIAL VEIN WAS ALSO DISCOVERED IN THE PROCESS OF LOCATING THE

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 13826015 ↗
• MalfunctionSep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "POWERGLIDE WHICH IS BELIEVED TO HAVE HAD A COMPLICATION FOLLOWING PLACEMENT." ADDITIONAL INFORMATION RECEIVED 08/20/2021 " A 10CM MIDLINE WAS PLACED IN THE RIGHT UPPER ARM WITH MINIMAL DIFFICULTY. UPON CHECKING FOR A BLOOD DRAW, THERE WAS SOME AIR WHICH IS NOT NORMAL AND DURING THE FLUSH OF THE LINE THE SALINE SEEPED THRU THE CATHETER WHERE IT MEETS THE GREEN HUB. THERE WASN¿T MOVEMENT OF THE NEEDLE AS WITH A DIFFICULTY INSERTION WHERE WAS A CHANCE THE CATHETER WAS KNICKED WITH THE NEEDLE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442040 ↗
• MalfunctionJul 22, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "WHEN ADVANCING THE DEVICE AFTER PLACING IT IN THE PATIENT, THE SAFETY COVER DID NOT COVER THE TIP OF THE NEEDLE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214449 ↗
• MalfunctionNov 4, 2020Insufficient Flow or Under Infusion

  IT WAS REPORTED BY HEALTH PROFESSIONAL "I INJECTED A MIDLINE AT 3MLS PER SECOND OF ISOVUE 300. PSI IS SET AT 325 WHICH THESE LINES ARE RATED FOR. DURING INJECTION 50MLS OF ISOVUE 300 WENT IN FINE THEN IT PRESSURED OUT AND THE REMAINING 35MLS THE INJECTOR BACKED IT DOWN TO 1ML PER SECOND. NOT SURE WHY THIS HAPPENED. THESE ARE OUR TYPICAL INJECTION PARAMETERS FOR MIDLINE INJECTIONS (THE MAX IS 5MLS FOR THE INJECTOR SETTING RANGE)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10786405 ↗
• InjuryDec 12, 2019Break; Break

  IT WAS REPORTED THE PATIENT REPORTED PAIN AT SITE WITH FLUSHING, SO MIDLINE WAS REMOVED. UPON PULLING THE MIDLINE OUT, IT WAS STATED ONLY THE HUB WITH A VERY SMALL PORTION OF THE CATHETER CAME OUT. NURSE WAS UNABLE TO VISUALIZE THE CATHETER. IR ATTEMPTED TO REMOVED THE PORTION OF CATHETER BUT WAS UNABLE. THE FLOOR PLACED A STANDARD IV.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459485 ↗
• InjuryMar 13, 2019Break

  IT WAS REPORTED THAT THE POWERGLIDE BROKE AT THE HUB. PATIENT WAS TAKEN TO SURGERY TO REMOVE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418270 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION THE WIRE DEPLOYED WELL, CATHETER WAS DIFFICULT, PULLED BACK CATHETER SHEER. IT WAS STATED WHEN THE DEVICE WAS REMOVED NO VISIBLE GUIDE WIRE TIP. X-RAY OF UPPER ARM DONE, NO VISIBLE FOREIGN BODY. NO HARM TO PATIENT HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7985593 ↗
• MalfunctionOct 19, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING INSERTION THE VEIN LOOKED GOOD ON ULTRASOUND, WIRE DEPLOYED WELL, BUT THERE WAS DIFFICULTY DEPLOYING CATHETER. THE RN ATTEMPTED TO RETRACT WIRE AND REMOVE DEVICE, DEVICE PULLED BACK GUIDE WIRE STILL IN ARM, ABLE TO MANUALLY REMOVE GUIDE WIRE WITH A LITTLE PULL. IT WAS STATED WIRE APPEARED INTACT, LATER TESTING REVEALED PATIENT HAD OLD VIETNAM SHRAPNEL IN HIS UPPER ARM. A NEW DEVICE WAS NOT PLACED AFTER THE EVENT. NO PATIENT HARM, X-RAY DONE ON UPPER ARM AND CHEST, LATER CT SCAN DETERMINED OLD SHRAPNEL IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985276 ↗