ARROW IPN040140 (REF EC-05400-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30801902126383), received between Aug 23, 2021 and Jul 25, 2025 — classified as 7 malfunctions.

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

• MalfunctionJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "THE CUSTOMER REPORTED THAT CONTINUOUS LEAKAGE WAS FOUND. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE."

  Patient problems: Insufficient Information

  MAUDE report 22620778 ↗
• MalfunctionMar 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND LEAKING WHEN USING ON PATIENT. CHANGE NEW TUBE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650772 ↗
• MalfunctionAug 15, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "UNABLE TO INJECT FLUID AFTER PLACEMENT IN PATIENT, CLOGGED LINE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992257 ↗
• MalfunctionAug 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT"(B)(6) 2024, AFTER PLACING INTO THE PATIENT'S BODY, WHEN INJECTING THE LIQUID, IT WAS FOUND THAT THE UPPER SECTION OF THE RETURN WINDOW WAS LEAKING, SO IT WAS REMOVED AND THE PATIENT'S BODY FLUID END WAS CLIPPED TO PROVIDE COMPLAINTS. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. A NEW DEVICE WAS USED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990128 ↗
• MalfunctionJan 9, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "THE PIPE IS BLOCKED AND THE CONNECTOR IS LEAKING.". NO MEDICAL INTERVENTION REQUIRED. PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED TO MDR NUMBER 3006425876-2024-00046.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474864 ↗
• MalfunctionAug 23, 2021No Flow; No Flow

  THE TUBE WAS BLOCKED WHEN DOING CLINICAL SETTING BEFORE USING ON THE SAME PATIENT IN THE SAME OPERATION. INVOLVED 2 PCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354415 ↗
• MalfunctionAug 23, 2021No Flow; No Flow

  THE TUBE WAS BLOCKED WHEN DOING CLINICAL SETTING BEFORE USING ON THE SAME PATIENT IN THE SAME OPERATION. INVOLVED 2 PCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354299 ↗

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-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