ARROW IPN920760Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10801902197570), received between Nov 28, 2025 and Sep 2, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (36 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Material Twisted/Bent; Material Too Soft/Flexible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571576 ↗
• MalfunctionAug 27, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482509 ↗
• MalfunctionAug 11, 2026Material Twisted/Bent

  Patient problems: Distress

  MAUDE report 50202490 ↗
• MalfunctionJul 29, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068827 ↗
• MalfunctionJul 28, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059354 ↗
• MalfunctionJul 28, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059241 ↗
• MalfunctionJul 22, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905455 ↗
• MalfunctionJul 14, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812773 ↗
• MalfunctionJul 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PLACEMENT OF A THORACIC EPIDURAL CATHETER, THE NEEDLE WAS OBSERVED TO BE EXCESSIVELY FLEXIBLE, AND IT WAS FOUND TO HAVE BENT DURING THE PROCEDURE." NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25754670 ↗
• MalfunctionApr 22, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "IN THE MATERNITY WARD, WHEN INSERTING THE EPIDURAL CATHETER, THE ANAESTHESIA INTERN NOTICED THAT THE CATHETER WAS KINKED BUT HE CONTINUED THE INSERTION. WHEN ATTEMPTING TO INSERT THE CATHETER BETWEEN THE VERTEBRAE, IT WOULD NOT PASS BECAUSE THE CATHETER WOULD NOT ADVANCE. THE CONSEQUENCE WAS DISCOMFORT AND A LONG PROCEDURE AND HEMATOMA FOR THE PATIENT POST THE PROCEDURE."

  Patient problems: Hematoma; Pain

  MAUDE report 24952001 ↗
• MalfunctionApr 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ANAESTHETIST USED THE DEVICE SET DURING UROLOGY PROCEDURE. ON MANIPULATION OR ADJUSTMENT OF THE INTRODUCER NEEDLE THE NEEDLE BENT. HE REMOVED THE NEEDLE. OPENED ANOTHER PACK, WHICH THEY HAVE BEEN USING BEFORE AND COMPLETED THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24869299 ↗
• MalfunctionApr 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "INCIDENT OCCURRED ON THURSDAY (B)(6) 2026, AN ANAESTHETIST IN THE OPERATING THEATRE. DURING THE INSERTION THE NEEDLE BENT WITHOUT EXCESSIVE FORCE BEING APPLIED. IT HAPPENED WITH 2 DIFFERENT NEEDLES SO A THIRD KIT WAS OPENED (WITH SUCCESS)." ASSOCIATED COMPLAINTS 3006425876-2026-00376 AND 3006425876-2026-00374.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813232 ↗
• MalfunctionApr 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "INCIDENT OCCURRED ON (B)(6) 2026, AN ANAESTHETIST IN THE OPERATING THEATRE. DURING THE INSERTION THE NEEDLE BENT WITHOUT EXCESSIVE FORCE BEING APPLIED. IT HAPPENED WITH 2 DIFFERENT NEEDLES SO A THIRD KIT WAS OPENED (WITH SUCCESS)." ASSOCIATED COMPLAINTS 3006425 876-2026-00375 AND 3006425876-2026-00374.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813215 ↗
• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "NEEDLE BENT DURING INSERTION: IT HAPPENED WITH 3 UNITS. ANOTHER KIT WAS USED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINTS 3006425876-2026-00367 AND 3006425876-2026-00368.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777332 ↗
• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "NEEDLE BENT DURING INSERTION: IT HAPPENED WITH 3 UNITS. ANOTHER KIT WAS USED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINTS 3006425876-2026-00366, 3006425876-2026-00367 AND 3006425876-2026-00368.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774202 ↗
• MalfunctionApr 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "NEEDLE BENT DURING INSERTION: IT HAPPENED WITH 3 UNITS. ANOTHER KIT WAS USED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINTS 3006425876-2026-00366, 3006425876-2026-00367 .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763718 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2026, THE HOSPITAL FACED 2 INCIDENTS OF NEEDLES BENT. NO CONSEQUENCE FOR THE PATIENT, NO MEDICAL INTERVENTION NECESSARY. THE DEVICE WAS REPLACED." ASSOCIATED COMPLAINTS 3006425876-2026-00357.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729380 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2026, THE HOSPITAL FACED 2 INCIDENTS OF NEEDLES BENT. NO CONSEQUENCE FOR THE PATIENT, NO MEDICAL INTERVENTION NECESSARY. THE DEVICE WAS REPLACED." ASSOCIATED COMPLAINTS 3006425876-2026-00356.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728287 ↗
• MalfunctionMar 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE CATHETER WOULD NOT ADVANCE. WHEN THE NEEDLE WAS REMOVED, IT WAS BENT. A SECOND KIT WAS OPENED, BUT THE NEEDLE WAS VERY FLEXIBLE AND BENT EASILY. THE NEEDLES ARE LESS RIGID THAN BEFORE AND WE DON'T HAVE THE SAME SENSATION WHEN INSERTING THEM. NO MAJOR CONSEQUENCES. APART FROM BEING PRICKED THREE TIMES." ASSOCIATED COMPLAINTS: 3006425876-2026-00314 AND 3006425876-2026-00355.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660334 ↗
• MalfunctionMar 23, 2026Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED THAT "THE CATHETER WOULD NOT ADVANCE. WHEN THE NEEDLE WAS REMOVED, IT WAS BENT. A SECOND KIT WAS OPENED, BUT THE NEEDLE WAS VERY FLEXIBLE AND BENT EASILY. THE NEEDLES ARE LESS RIGID THAN BEFORE AND WE DON'T HAVE THE SAME SENSATION WHEN INSERTING THEM. NO MAJOR CONSEQUENCES. APART FROM BEING PRICKED THREE TIMES." ASSOCIATED COMPLAINTS 3006425876-2026-00321, AND 3006425876-2026-00355.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660328 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2026, AN INCIDENT OCCURRED WITH A FEMALE PATIENT IN THE MATERNITY WARD. THE TUOHY NEEDLE IN THE KIT BENT VERY EASILY AT ITS DISTAL END DURING EPIDURAL INSERTION. EPIDURAL INSERTION WAS VERY DIFFICULT AND FAILED. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Insufficient Information

  MAUDE report 24637241 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2026, AN INCIDENT OCCURRED WITH A FEMALE PATIENT IN THE MATERNITY WARD. THE TUOHY NEEDLE IN THE KIT BENT VERY EASILY AT ITS DISTAL END DURING EPIDURAL INSERTION. EPIDURAL INSERTION WAS VERY DIFFICULT AND FAILED. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Insufficient Information

  MAUDE report 24637219 ↗
• MalfunctionMar 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "DURING THE EPIDURAL PROCEDURE THE TUOHY NEEDLE BENT. IT WAS NECESSARY TO RE-POSITION AFTER BONE CONTACT. A NEW DEVICE WAS USED. PATIENT IS FINE. NO CLINICAL CONSEQUENCE, NO MEDICAL INTERVENTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596819 ↗
• MalfunctionMar 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "DURING THE EPIDURAL PROCEDURE THE TUOHY NEEDLE BENT. IT WAS NECESSARY TO RE-POSITION AFTER BONE CONTACT. A NEW DEVICE WAS USED. PATIENT IS FINE. NO CLINICAL CONSEQUENCE, NO MEDICAL INTERVENTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588392 ↗
• MalfunctionMar 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "DURING THE EPIDURAL PROCEDURE THE TUOHY NEEDLE BENT. IT WAS NECESSARY TO RE-POSITION AFTER BONE CONTACT. A NEW DEVICE WAS USED. PATIENT IS FINE. NO CLINICAL CONSEQUENCE, NO MEDICAL INTERVENTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588381 ↗

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-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-1174-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
• 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