ARROW IPN924969Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902209556), received between Nov 21, 2022 and Jun 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

8 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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2371-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Material Separation; Defective Device

  RN REMOVED EPIDURAL CATHETER PER ORDER. WHEN REMOVING CATHETER, THE TIP WAS NOT INTACT. CRNA [CERTIFIED REGISTERED NURSE ANESTHETIST] NOTIFIED. NEURO CONSULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193522 ↗
• MalfunctionDec 20, 2022Material Twisted/Bent; Material Twisted/Bent

  REPORTED ISSUE: PEOPLE CANNOT GET THE SPINAL NEEDLE THROUGH THE END OF THE T OR PASS THE CATHETER. IT BENDS UPON CONTACT WITH BONE. THERE WAS NO REPORTED PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017990 ↗
• MalfunctionNov 21, 2022Material Twisted/Bent; Material Twisted/Bent

  REPORTED ISSUE: IT WAS REPORTED THAT THE END OF THE TUOHY HAS FOLDED UP ON ITSELF AND THE RESIDENTS OR ATTENDINGS HAVE BEEN UNABLE TO PASS THE SPINAL NEEDLE OR CATHETER THROUGH. UPON FURTHER QUESTIONING THE DOCTOR STATED THAT SHE WAS NOT SURE THAT ANYTHING BROKE/CHIPPED OFF IN THE PATIENT AND THAT THE RESIDENT THAT WAS PLACING THE EPIDURAL CLAIMED THOUGHT IT CHIPPED BUT I DID NOT SEE ANYTHING AT THE END OF THE NEEDLE. THE TIP MAY HAVE FOLDED OVER ITSELF. THE BEVEL OF NEEDLES APPEARS FLIMSY , AND I THINK THEY FOLD OVER THEMSELVES AND OCCLUDE. SHE OPENED A SECOND KIT AND PLACED A NEW EPIDURAL. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834300 ↗

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-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-1172-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
• 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