ARROW IPN920780Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902197730), received between Jan 24, 2023 and Aug 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144557 ↗
• MalfunctionApr 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT " AN INCIDENT OCCURRED ON (B)(6) 2026. WHILE INSERTING THE EPIDURAL, THE NEEDLE BENT, AND THE ANAESTHETIST STATED THAT THEY HAD NOT APPLIED EXCESSIVE FORCE. DEVICE WAS CHANGED, AND THERE WAS A DELAY IN PAIN MANAGEMENT. "

  Patient problems: Insufficient Information

  MAUDE report 24870622 ↗
• MalfunctionMar 9, 2026Material Twisted/Bent

  IT WAS REPORTED THAT " AN INCIDENT OCCURRED ON (B)(6) 2026. THE EPIDURAL NEEDLE BENT SIGNIFICANTLY IN THE FEMALE PATIENT'S BACK. APART FROM A LONGER PROCEDURE REQUIRING TWO PUNCTURES, THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE DEVICE WAS NOT KEPT, BUT PHOTOS ARE AVAILABLE IN THE ATTACHMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543166 ↗
• MalfunctionMar 4, 2026Fluid/Blood Leak

  EVENT DESCRIPTION: "INCIDENT OCCURRED ON (B)(6) 2026. THE LOW-PRESSURE SYRINGE LEAKED AT THE LEVEL OF THE PLUNGER. PATIENT HAD A PUNCTURE OF THE DURAL. BLOOD PATCH WAS NEEDED TO TREAT."

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24504943 ↗
• MalfunctionJan 24, 2023Pressure Problem; Pressure Problem

  REPORTED EVENT: DURING THE INSERTION OF THE EPIDURAL CATHETER, WE OBSERVED THAT THE LOR SYRINGE WAS PRESENTING A RESISTANCE DURING ITS USE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233966 ↗

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-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