ARROW IPN046378 (REF EC-05400-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 40801902128407), received between Mar 3, 2021 and Mar 29, 2023 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “No Flow” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Material Separation; Material Separation

  REPORTED ISSUE: THE DOCTOR FOUND SWG SEPARATED WHEN USING IT ON THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638227 ↗
• MalfunctionFeb 8, 2023Delivered as Unsterile Product; Material Split, Cut or Torn; Delivered as Unsterile Product; Material Split, Cut or Torn

  REPORTED EVENT: THE DOCTOR FOUND PACKAGE DAMAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE. NO IMPACT ON PATIENT. ON 02 FEB 2023 ADDITIONAL INFORMATION INDICATES THAT THE STERILE PACKAGE WAS FOUND TORN AT THE CORNER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324245 ↗
• MalfunctionOct 12, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE TUBE WAS BLOCKED WHEN USING ON THE PATIENT. IT WAS THEN CHANGED TO A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586894 ↗
• MalfunctionSep 24, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER WAS BLOCKED AND UNABLE TO INJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476991 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CATHETER WAS REMOVED WITHIN 48HR AFTER FIRST SURGERY AND THE BLOOD CLOT WAS FOUND 40HRS AFTER THE REMOVAL. THERE WAS NO CATHETER DEFECT. BLOOD CLOTS FORMED AT THE PUNCTURE SITE; THE DOCTOR PERFORMED LAMINAR DECOMPRESSION SURGERY WITH BOTH PATIENTS TO STOP THE BLEEDING.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14695016 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CATHETER WAS REMOVED WITHIN 48HR AFTER FIRST SURGERY AND THE BLOOD CLOT WAS FOUND 40HRS AFTER THE REMOVAL. THERE WAS NO CATHETER DEFECT. BLOOD CLOTS FORMED AT THE PUNCTURE SITE; THE DOCTOR PERFORMED LAMINAR DECOMPRESSION SURGERY WITH BOTH PATIENTS TO STOP THE BLEEDING.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694981 ↗
• MalfunctionDec 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE TUBE WAS LEAKING WHEN USING ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112786 ↗
• MalfunctionDec 29, 2021Obstruction of Flow; Obstruction of Flow

  THE TUBE WAS BLOCKED WHEN USING ON THE PATIENT. INVOLVED 2 PCS. THIS EVENT OCCURRED ON SAME PATIENT AT THE SAME TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112437 ↗
• MalfunctionDec 29, 2021Obstruction of Flow; Obstruction of Flow

  THE TUBE WAS BLOCKED WHEN USING ON THE PATIENT. INVOLVED 2 PCS. THIS EVENT OCCURRED ON SAME PATIENT AT THE SAME TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112409 ↗
• MalfunctionSep 29, 2021No Flow; No Flow

  THE TUBE WAS BLOCKED WHEN USING ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547630 ↗
• MalfunctionAug 26, 2021Unsealed Device Packaging; Unsealed Device Packaging

  THE DOCTOR DID INVENTORY CHECK AND FOUND THAT THE PACKAGE OPENING WAS NOT COMPLETELY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372560 ↗
• MalfunctionAug 26, 2021Unsealed Device Packaging; Unsealed Device Packaging

  THE DOCTOR DID INVENTORY CHECK AND FOUND THAT THE PACKAGE OPENING WAS NOT COMPLETELY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372534 ↗
• MalfunctionAug 26, 2021Unsealed Device Packaging; Unsealed Device Packaging

  THE DOCTOR DID INVENTORY CHECK AND FOUND THAT THE PACKAGE OPENING WAS NOT COMPLETELY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372511 ↗
• MalfunctionAug 26, 2021Unsealed Device Packaging; Unsealed Device Packaging

  THE DOCTOR DID INVENTORY CHECK AND FOUND THAT THE PACKAGE OPENING WAS NOT COMPLETELY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372424 ↗
• MalfunctionAug 26, 2021Unsealed Device Packaging; Unsealed Device Packaging

  THE DOCTOR DID INVENTORY CHECK AND FOUND THAT THE PACKAGE OPENING WAS NOT COMPLETELY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372297 ↗
• MalfunctionApr 19, 2021No Flow; No Flow

  THE TUBE WAS BLOCKED WHEN USING ON THE PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685956 ↗
• MalfunctionMar 3, 2021No Flow; No Flow

  IT WAS REPORTED THAT THE DOCTOR FOUND THE LIQUID MEDICINE COULD NOT BE INJECTED INTO THE CATHETER; CATHETER BLOCKED DURING EPIDURAL SURGERY ON PATIENT. REPLACED ANOTHER LOT PRODUCT AND COMPLETED THE TREATMENT. PATIENT CONDITION IS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407570 ↗
• MalfunctionMar 3, 2021No Flow; No Flow

  IT WAS REPORTED THAT THE DOCTOR FOUND THE LIQUID MEDICINE COULD NOT BE INJECTED INTO THE CATHETER; CATHETER BLOCKED DURING EPIDURAL SURGERY ON PATIENT. REPLACED ANOTHER LOT PRODUCT AND COMPLETED THE TREATMENT. PATIENT CONDITION IS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407560 ↗
• MalfunctionMar 3, 2021No Flow; No Flow

  IT WAS REPORTED THAT THE DOCTOR FOUND THE LIQUID MEDICINE COULD NOT BE INJECTED INTO THE CATHETER; CATHETER BLOCKED DURING EPIDURAL SURGERY ON PATIENT. REPLACED ANOTHER LOT PRODUCT AND COMPLETED THE TREATMENT. PATIENT CONDITION IS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407544 ↗

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-1172-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
• Z-1177-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
• Z-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
• Z-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1