ARROW IPN046629 (REF SJ-05501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 50801902013694), received between Nov 12, 2019 and Dec 18, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "RN CONTACTED CRNA STATING THEY WERE HAVING DIFFICULTY REMOVING THE PATIENT'S EPIDURAL CATHETER. THE CATHETER HAD BEEN UNTAPPED; CRNA PULLED ON THE TAPE/CATHETER AND THE CATHETER APPEARED TO COME OUT WITHOUT SIGNIFICANT DIFFICULTY AND APPEARED TO BE INTACT. AFTERWARDS, CRNA CONTACTED THEIR OB COLLEAGUES AND DISCUSSED THE CASE AND DECIDED THE PRUDENT COURSE OF ACTION WOULD BE TO SIMPLY OBTAIN AN AP AND LATERAL LUMBER SPINE X-RAY DUE TO DIFFICULT EPIDURAL CATHETER REMOVAL. THEY WERE NOTIFIED AT 22:47 HOURS ON (B)(6) 2025 THAT THE X'RAY WAS CLEAR AND THE PATIENT WAS DOING FINE, WITH NO COMPLICATIONS VOICED. AGAIN, NOTIFIED AT 16:40 HOURS ON (B)(6) BY (B)(6) CRNA THAT THE X-RAY HAD BEEN READ AGAIN AND WAS FOUND TO BE CLEAR THEN READ FOR A 3RD TIME AND A PORTION OF THE EPIDURAL CATHETER WAS IDENTIFIED. THE PATIENT WAS CONTACTED AND REQUESTED TO RETURN TO THE HOSPITAL FOR ED EVALUATION. THE PATIENT RETURNED AND A CT WAS OBTAINED. RESULTS OF CT SPINE LUMBAR WITH IV CONTRAST: THERE IS A FRAGMENT OF AN EPIDURAL CATHETER THAT COURSES JUST INFERIOR AND LATERAL TO THE L3 SPINOUS PROCESS. THIS CATHETER ENTERS THE SPINAL CANAL AND MAKES SEVERAL LOOPS IN THE EPIDURAL SPACE A

  Patient problems: Foreign Body In Patient

  MAUDE report 23836286 ↗
• InjuryFeb 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "ON (B)(6) 2024, WE HAD A LABORING PATIENT WHO HAD AN EPIDURAL CATHETER PLACED FOR PAIN CONTROL BY ANESTHESIA AT 1650. ONCE THE PATIENT DELIVERED, A REGISTERED NURSE (RN) ATTEMPTED TO REMOVE THE EPIDURAL CATHETER WITH SLIGHT RESISTANCE NOTED WITH GENTLE TRACTION. THE RN DIRECTED PATIENT TO CURL FORWARD. THE EPIDURAL CATHETER NOTED TO REMOVE WITH GENTLE, STEADY TRACTION. DURING THIS, THE PATIENT WAS NOTED TO SLIGHTLY ADJUST UPRIGHT DURING THIS PROCESS. THE EPIDURAL CATHETER CAME OUT AND APPEARED SHEARED WITH NO BLACK TIP COLOR MARKING OBSERVED. THE PATIENT HAD THE EPIDURAL CATHETER REMOVED AT ANOTHER ACUTE CARE FACILITY ON (B)(6) 2024 AFTER DISCHARGING FROM (B)(6). WE HAD THIS EVENT INVESTIGATED AND THE CATHETER WAS REMOVED ACCORDING TO POLICY. THE PATIENT IS REPORTED TO BE DOING WELL."

  Patient problems: Foreign Body In Patient

  MAUDE report 21383869 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED "WE HAD AN EPIDURAL CATHETER THAT BROKE OFF IN A PATIENT BACK DURING REMOVAL THAT I WAS ABLE TO STILL RETRIEVE LATER ON THAT MORNING." ADDITIONAL INFORMATION RECEIVED REPORTS "AFTERSEVERAL HOURS AN ATTEMPT WAS MADE WITH CLAMP TO REMOVE WITH GENTLETRACTION AND IT WAS SUCCESSFUL. THERE WAS NO ISSUES RELATING TO THE PATIENT. THE RESIDUAL CATHETER WAS REMOVED WITH NO PATIENT HARM." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DISCHARGED HOME".

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

  MAUDE report 20189216 ↗
• MalfunctionDec 28, 2021Obstruction of Flow; Obstruction of Flow

  ANESTHESIOLOGIST CONNECTED THE SNAPLOCK ADAPTER ONTO THE FLEXTIP PLUS CATHETER AND COULD NOT INJECT MEDICATION FOR PAIN RELIEF. ONCE REMOVED THE DOCTOR TRIED TO INJECT AGAIN AND COULD NOT PASS ANY FLUID. CUSTOMER PULLED ADDITIONAL PRODUCT THAT WAS THE SAME LOT NUMBER AND HAS 14 ADDITIONAL KITS THAT THEY WANT TO RETURN FOR CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097675 ↗
• MalfunctionDec 7, 2021No Flow; No Flow

  ANESTHESIOLOGIST CONNECTED THE SNAPLOCK ADAPTER ONTO THE FLEXTIP PLUS CATHETER AND COULD NOT INJECT MEDICATION FOR PAIN RELIEF. ADDITIONAL INFORMATION: THE EPIDURAL CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER FROM A NEW EPIDURAL KIT WITH A DIFFERENT LOT NUMBER. THE NEW CATHETER WAS PLACED AND DOSED WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953922 ↗
• MalfunctionNov 26, 2021Device Contamination with Chemical or Other Material

  WHILE THE ANESTHESIOLOGIST WAS PREPARING THE EPIDURAL TRAY CONTENTS FOR INSERTION, HE NOTICED THE CONTENTS IN THE LIDOCAINE VIAL DID NOT CONTAIN ANY LIQUID ONLY CRYSTALS. THE ANESTHESIOLOGIST DISCARDED THE ENTIRE CONTENTS OF THE TRAY AND OBTAINED A NEW ONE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12883029 ↗
• MalfunctionAug 16, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  WHEN PLACING AN EPIDURAL FOR LABOR ANALGESIA, I NOTED A SMALL "FLECK" OF MATERIAL IN THE GLASS LOSS OR RESISTANCE SYRINGE. I HAD ALREADY PREPPED AND DRAPED THE BACK USING NORMAL STERILE TECHNIQUE, INJECTED LOCAL ANESTHESIA USING THE LOCAL ANESTHESIA SYRINGE AND PLACED THE TUOHY EPIDURAL NEEDLE. I THEN PICKED UP THE GLASS LOSS OF RESISTANCE SYRINGE WHICH HAD BEEN FILLED WITH 3 CC OF NS FROM THE GLASS VIAL IN THE KIT USING A FILTER NEEDLE. WHEN I CONNECTED THE SYRINGE I NOTICED THE "FLECK" OF DARK MATERIAL IN THE GLASS SYRINGE WHICH IS NOT NORMALLY PRESENT. BECAUSE OF THIS FOREIGN SUBSTANCE, I ABORTED THE PROCEDURE WITH THIS KIT. I INFORMED THE RN AND THE PATIENT AS TO THE ISSUE AND GOT A NEW KIT, NEW STERILE GLOVES AND REPREPPED AND DRAPED THE BACK USING THE NEW KIT. USING THE NEW KIT AND STANDARD STERILE PREP AND TECHNIQUE I PLACED THE EPIDURAL UNEVENTFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325521 ↗
• MalfunctionJul 13, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ANESTHESIA TECH NOTIFIED ME MULTIPLE CRNAS AND MDS HAVE EXPERIENCED ISSUES WITH CATHETER NOT THREADING THROUGH NEEDLE ONCE EPIDURAL SPACE HAS BEEN LOCATED REQUIRING RESTICKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158323 ↗
• MalfunctionJul 13, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ANESTHESIA TECH NOTIFIED ME THAT MULTIPLE CRNAS AND MDS HAVE EXPERIENCED ISSUES WITH CATHETER NOT THREADING THROUGH NEEDLE ONCE EPIDURAL SPACE HAS BEEN LOCATED REQUIRING RESTICKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158307 ↗
• MalfunctionJul 13, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ANESTHESIA TECH NOTIFIED ME THAT MULTIPLE CRNAS AND MDS HAVE EXPERIENCED ISSUES WITH CATHETER NOT THREADING THROUGH NEEDLE ONCE EPIDURAL SPACE HAS BEEN LOCATED REQUIRING RESTICKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158273 ↗
• MalfunctionNov 12, 2019Break; Physical Resistance/Sticking

  PATIENT WAS POSITIONED TO REMOVE EPIDURAL CATHETER. RESISTANCE WAS MET. PATIENT REPOSITIONED, MILD RESISTANCE MET AS CATHETER WAS REMOVED, FELT A SNAP AND CATHETER CAME OUT WITHOUT TIP INTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9309471 ↗

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-1177-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
• Z-1174-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
• 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