ARROW IPN038423Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902140019), received between Apr 30, 2021 and Apr 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2021Material Fragmentation

  THE ANESTHESIOLOGIST WAS PLACING AN EPIDURAL CATHETER IN A PATIENT IN LABOR. DURING PLACEMENT OF THE CATHETER, IT WAS NOTED THAT CIRCULAR METAL FRAGMENTS/SHAVINGS CAME OUT OF THE TOUGHY NEEDLE INCLUDED IN THE EPIDURAL KIT. THIS IS THE SECOND SUCH EVENT FOR THIS KIT IN THE LAST 7 MONTHS. THERE IS A RISK OF INTRODUCING METAL FRAGMENTS AND DEBRIS INTO THE EPIDURAL SPACE. OUR UNDERSTANDING IS THAT THAT TOUGHY NEEDLE IS MADE OF NON-MRI COMPATIBLE METAL INCREASING THE RISK TO THE PATIENT IF UNKNOWINGLY RETAINED DURING INSERTION. THE PATIENT WAS NOT HARMED IN THIS EVENT, BUT THERE ARE CONCERNS OVER THE QUALITY OF THE MANUFACTURING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752147 ↗

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-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-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
• Z-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN