ARROW IPN045607Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 60801902005139), received between Apr 18, 2019 and Jun 18, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 reports).

9 other recalls cover devices cleared under the same FDA submission (K140110); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• InjuryJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING REMOVAL OF EPIDURAL CATHETER, THE PLASTIC PORTION WAS RETAINED IN THE PATIENT AFTER ATTEMPTING A REMOVAL. THE REST OF THE CATHETER CAME OUT EASILY WITH NO RESISTANCE. PART OF THE CATHETER IS STILL INSIDE THE PATIENT, AROUND 5.5CM LEFT. NO EXISTING SYMPTOMS AS OF NOW. DOCTOR THINKS THAT THE BEVEL EDGE OF THE HYPODERMIC NEEDLE MIGHT HAVE SHEARED THE CATHETER." ADDITIONAL INFORMATION: "PATIENT WAS HAVING BREAKTHROUGH PAIN DURING LABOR ANALGESIA, CLINICIAN DECIDED TO REPLACE CATHETER DURING LABOR. THEY PULLED THE CATHETER, ABLE TO REMOVE MOST OF IT, BUT THE DISTAL END (ABOUT 5 CM OF THE PLASTIC PORTION) WAS REMAINING IN THE PATIENT'S BODY. THERE WAS NO TUGGING WHEN REMOVING, NO RESISTANCE, IT WAS EASY TO REMOVE." ASSOCIATED COMPLAINTS 9680794-2025-00498.

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 22282169 ↗
• InjuryJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING REMOVAL OF EPIDURAL CATHETER, THE PLASTIC PORTION WAS RETAINED IN THE PATIENT AFTER ATTEMPTING A REMOVAL. THE REST OF THE CATHETER CAME OUT EASILY WITH NO RESISTANCE. PART OF THE CATHETER IS STILL INSIDE THE PATIENT, AROUND 5.5CM LEFT. NO EXISTING SYMPTOMS AS OF NOW. DOCTOR THINKS THAT THE BEVEL EDGE OF THE HYPODERMIC NEEDLE MIGHT HAVE SHEARED THE CATHETER." ADDITIONAL INFORMATION: "PATIENT WAS HAVING BREAKTHROUGH PAIN DURING LABOR ANALGESIA, CLINICIAN DECIDED TO REPLACE CATHETER DURING LABOR. THEY PULLED THE CATHETER, ABLE TO REMOVE MOST OF IT, BUT THE DISTAL END (ABOUT 5 CM OF THE PLASTIC PORTION) WAS REMAINING IN THE PATIENT'S BODY. THERE WAS NO TUGGING WHEN REMOVING, NO RESISTANCE, IT WAS EASY TO REMOVE." ASSOCIATED COMPLAINTS 9680794-2025-00499.

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 22282090 ↗
• MalfunctionMar 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "ARROW EPIDURAL FLEX TIP ARE HAVING ISSUES WITH THE 17G TUOHY NEEDLES. THEY ARE BENDING WITH EXCESSIVE FREQUENCY CREATING A PATIENT SAFETY ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696472 ↗
• InjuryMay 9, 2024Material Separation; Material Separation

  IT IS REPORTED THAT: "I BEGAN THE EPIDURAL IN THE SITTING POSITION, FOLLOWED STERILE TECHNIQUE AND HAD A FIRST PASS LOSS OF RESISTANCE AT THE L3/4 LEVEL. HER LIGAMENT WAS FIRM AND GIVEN HER HEIGHT I WAS NOT SURPRISED TO FIND THE EPIDURAL SPACE APPROXIMATELY 1-1.5CM FROM THE HUB OF THE NEEDLE. THIS WOULD GIVE A LOSS OF RESISTANCE AT A DEPTH OF APPROXIMATELY 7 CM. I THREADED THE CATHETER APPROX 4CM INTO THE EPIDURAL SPACE AND WHILE DOING SO THE BACK OF THE CATHETER SLID ONTO A NON-STERILE AREA. GIVEN HER STAGE IN LABOR I ELECTED TO PULL THE CATHETER BACK THROUGH THE TUOHY AND REPLACE IT. I PULLED LIGHTLY AND MET SLIGHT RESISTANCE. MY SECOND PULL WAS SLIGHTLY MORE FORCED BUT STILL IN THE MILD CATEGORY AND THE CATHETER UNWOUND QUICKLY IN FRONT OF ME. THE CATHETER DID NOT PULL OUT INTACT A FEW CENTIMETERS THEN UNWIND. IT CAME APART QUICKLY WITHOUT PULLING BACK INTACT AT ALL. THE WIRE OF THE EPIDURAL REMAINED IN THE NEEDLE, AND I WAS HOLDING ONLY A SHORT PIECE OF CATHETER. GIVEN HER DEPTH TO THE EPIDURAL SPACE FROM THE SKIN AND HAVING ALREADY THREADED THE CATHETER INTO THE EPIDURAL SPACE, I WAS CONFIDENT THAT SEVERAL CENTIMETERS OF CATHETER REMAINED. I PULLED THE NEEDLE BACK SLOWLY AT TH

  Patient problems: Foreign Body In Patient

  MAUDE report 19275613 ↗
• MalfunctionFeb 29, 2024Difficult to Advance; Difficult to Advance

  THE REPORT STATES, "I'VE ENCOUNTERED CONFIRMED LOSS OF RESISTANCE, BUT THE EPIDURAL CATHETER WOULD NOT PASS INTO THE PATIENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "PATIENT LAST WEEK HAD AN INADVERTENT DURAL PUNCTURE. THE EPIDURAL CATHETER WOULD NOT ADVANCE, AND SO THE TOUHY NEEDLE WAS ADVANCED". THE PATIENT STATUS IS REPORTED AS "BACK TO NORMAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18811791 ↗
• MalfunctionJan 8, 2024Material Twisted/Bent; Material Twisted/Bent

  THE REPORT STATES "THE EPIDURAL CATHETER WOULD BUCKLE AT TIP WHILE PLACING DURING PROCEDURE". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION IS UNKNOWN AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464960 ↗
• MalfunctionJan 8, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT: CATHETERS IN KIT WILL NOT THREAD PROPERLY AND NEEDS TO USE MUTLIPLE KITS ON ONE PATIENT. ADDITIONAL INFORMATION: THE CATHETER SIMPLY WON'T PASS INTO PATIENTS. IT'S NOT UNCOMMON FOR THERE TO BE A SMALL AMOUNT OF RESISTANCE AS THE CATHETER EXITS TUOY INTO PATIENT. NO ADVERSE OUTCOMES. ASSOCIATED COMPLAINTS 9680794-2024-00035, 9680794-2024-00036, 9680794-2024-00037, 9680794-2024-00038, AND 9680794 -2024-00039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462637 ↗
• MalfunctionJan 5, 2024Material Twisted/Bent; Material Twisted/Bent

  THE REPORT STATES "THE EPIDURAL CATHETER WOULD BUCKLE AT TIP WHILE PLACING DURING PROCEDURE". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION IS UNKNOWN AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456645 ↗
• MalfunctionDec 13, 2021Difficult to Remove; Separation Problem; Difficult to Remove; Separation Problem

  INCIDENT HAPPENED LATE ON A SATURDAY NIGHT SHIFT AND THE DOCTOR WAS MADE AWARE AT A LATER DATE AND WAS TASKED WITH HANDLING THE COMPLAINT. NURSES PULL EPIDURALS OUT IN OB AND DURING REMOVAL THE EPIDURAL CATHETER WAS BROKEN , AND THE TIP REMAINS IN THE PATIENT. THE TIP IS STILL IN THE PATIENT AND X-RAY SHOWS THE WIRE IS OUT. A DECISION HAS NOT BEEN MADE AS WHETHER TO REMOVE OR LEAVE THE TIP IN. PATIENT WAS COMPLAINING ABOUT PAIN IN HER BACK AFTER FINDING OUT BUT IS OTHERWISE STABLE. REFRESHER TRAINING IS GOING TO BE SCHEDULED WITH ARROW REPRESENTATIVE AND NURSING STAFF FOR EPIDURAL REMOVAL.

  Patient problems: Pain

  MAUDE report 12984399 ↗
• MalfunctionNov 19, 2021Difficult to Advance; Difficult to Advance

  CATHETER FAILED TO THREAD THROUGH THE TIP OF THE TUOHY NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844902 ↗
• MalfunctionNov 10, 2021Break; Break

  CATHETER BROKE (POLYURETHANE) AS THE CATHETER WAS BEING PLACED ON AN OB PATIENT. NO PATIENT INJURY OR CONSEQUENCE. ADDITIONAL INFORMATION: WHAT HAPPENED WAS I DID A COMBINED SPINAL-EPIDURAL FOR THE PATIENT. WE HAVE A SEPARATE CSE PACK WHICH COMES WITH AN EPIDURAL NEEDLE AND SPINAL NEEDLE TOGETHER. I OPENED THAT PACK AND ADDED IT TO THE EPIDURAL KIT. I USED THE EPIDURAL NEEDLE THAT COMES WITH THE SPINAL NEEDLE, NOT THE ONE IN THE KIT, TO FIND THE EPIDURAL SPACE. I THEN PUT THE SPINAL NEEDLE THROUGH THE EPIDURAL NEEDLE TO GIVE THE SPINAL DOSE THEN THREADED THE EPIDURAL CATHETER THAT COMES WITH THE KIT THROUGH THE EPIDURAL NEEDLE. THIS IS HOW I DO ALL OF MY CSES FOR LABOR AS WELL (THIS HAPPENED TO BE A C-SECTION). THE CATHETER EASILY THREADED IN THROUGH THE NEEDLE AND I REMOVED THE NEEDLE OVER IT. IT WAS BASICALLY DONE AT THAT POINT AND I PUT A TEGADERM OVER THE EPIDURAL CATHETER I LIFTED UP THE CATHETER ON THE PATIENTS BACK TO TAPE IT TO HER BACK AND THE TOP PART JUST BROKE OFF. SO, A LARGE PART OF THE CATHETER REMAINED IN HER BACK BUT IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789094 ↗
• MalfunctionOct 18, 2021Difficult to Remove; Difficult to Remove

  DURING MID PROCEDURE THE NEEDLE TIP BROKE WHILE STILL INSERTED IN THE PATIENT UPDATE: THE NEEDLE NEVER BROKE OFF IN THE PATIENT. THE EPIDURAL WAS PLACED WITHOUT ISSUES. HOWEVER, ONCE THE STAFF TRIED TO REMOVE THE EPIDURAL, THEY MET RESISTANCE. THEY TRIED FLUSHING IT, AMBULATING THE PATIENT, AND REPOSITIONING THE PATIENT AS WELL AS OTHER MODALITIES. UNFORTUNATELY, IT WAS NOTED THAT THE CATHETER WHICH WAS CLOSE TO THE SKIN ENTRANCE LOOKED FRAYED. UPON TRYING TO REMOVE IT AFTER MULTIPLE ATTEMPTS, IT BROKE AT THE ENTRANCE TO THE SKIN. THE PATIENT HAS HAD NO COMPLICATIONS AND WAS DISCHARGED HOME THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647792 ↗
• InjuryOct 18, 2021Break; Break

  WE HAD AN INCIDENT AT ONE OF OUR FACILITIES WHERE THE NEEDLES BROKE FROM TWO OF THESE KITS, AND ONE PATIENT HAD TO BE TAKEN TO SURGERY TO GET IT REMOVED. WE ARE IN THE PROCESS OF GETTING THE LOT INFORMATION AND HOW MUCH INVENTORY IS AFFECTED IN THE IU SYSTEM, BUT WE WILL NEED TO GET REPLACEMENT PRODUCT SENT ASAP. ADDITIONAL INFORMATION: THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. SHE HAD A SURGICAL REMOVAL OF THE CATHETER PIECE BY OUR NEUROSURGEON. IT WAS COMPLETELY REMOVED AND DISCARDED. THERE HAS NOT BEEN A SECOND PATIENT TO MY KNOWLEDGE THAT HAD IT BREAK WHILE STILL IN THE PATIENT. WE HAVE A COUPLE THAT WERE DIFFICULT TO REMOVE BUT WERE REMOVED FULLY INTACT AND THEN BROKE EXTERNALLY IN THE CRNAS HANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647741 ↗
• MalfunctionOct 18, 2021Difficult to Remove; Difficult to Remove

  NOTE: BASED ON THE ADDITIONAL INFORMATION A SECOND REPORTED EVENT IS CODED AS SERIOUS INJURY. WE HAD AN INCIDENT AT ONE OF OUR FACILITIES WHERE THE NEEDLES BROKE FROM TWO OF THESE KITS AND ONE PATIENT HAD TO BE TAKEN TO SURGERY TO GET IT REMOVED. WE ARE IN THE PROCESS OF GETTING THE LOT INFORMATION AND HOW MUCH INVENTORY IS AFFECTED IN THE IU SYSTEM BUT WE WILL NEED TO GET REPLACEMENT PRODUCT SENT ASAP. ADDITIONAL INFORMATION: THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. SHE HAD A SURGICAL REMOVAL OF THE CATHETER PIECE BY OUR NEUROSURGEON. IT WAS COMPLETELY REMOVED AND DISCARDED. THERE HAS NOT BEEN A SECOND PATIENT TO MY KNOWLEDGE THAT HAD IT BREAK WHILE STILL IN THE PATIENT. WE HAVE A COUPLE THAT WERE DIFFICULT TO REMOVE BUT WERE REMOVED FULLY INTACT AND THEN BROKE EXTERNALLY IN THE CRNAS HANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647689 ↗
• MalfunctionOct 14, 2021Difficult to Advance; Difficult to Advance

  THE INABILITY TO THREAD A CATHETER THROUGH A BROKEN TUOHY NEEDLE. ADDITIONAL INFORMATION: THE CATHETER COULD NOT ADVANCE THROUGH THE NEEDLE. I DO NOT KNOW IF THE NEEDLE ACTUALLY BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12635735 ↗
• MalfunctionSep 23, 2021Material Twisted/Bent; Material Twisted/Bent

  THE EPIDURAL CATHETER KINK BADLY DURING INSERTION AND COULD NOT PASS THROUGH THE NEEDLE. THIS HAS BEEN AN ONGOING PROBLEM WITH OUR CATHETER. A NEW NEEDLE PUNCTURE WAS REQUIRED; PROVIDER SWITCHED TO BRAUN KIT AND WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519063 ↗
• MalfunctionMay 24, 2019Detachment of Device or Device Component

  EPIDURAL CATHETER ATTEMPTED TO ADVANCE WITH PLACEMENT, CATHETER DID NOT THREAD AND WAS WITHDRAWN. THE TIP MARKER DID NOT COME BACK WHEN CATHETER WAS REMOVED. LESS THAN 2MM OF THE TIP OF THE EPIDURAL CATHETER WAS RETAINED. EPIDURAL CATHETER CAME FROM ANESTHESIA KIT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8640127 ↗
• InjuryApr 18, 2019Fracture

  EPIDURAL CATHETER FRACTURED WHEN BEING REMOVED AND REQUIRED SURGICAL INTERVENTION TO REMOVE RETAINED CATHETER PORTION. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8531448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140110. One submission often covers many models, so check the product and lot details in each record.

• Z-2371-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION K
• Z-1913-2026 · Mar 11, 2026 · Open, Classified
  FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arr
• Z-2288-2020 · May 8, 2020 · Open, Classified
  Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05
• Z-1174-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
• Z-1177-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
• Z-1172-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
• Z-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
• Z-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC