ARROW IPN045707Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801902051387), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 4, 2021Material Separation; Material Separation

  THE DOCTOR WAS PLACING AN EPIDURAL PRIOR TO A PROCEDURE AND THE CIRCULATING NURSE NOTICED A HOLE IN THE CATHETER. THEY DISCONTINUED USE OF THE CATHETER AND UPON REMOVAL THE CATHETER TIP BROKE AND THE PATIENT RETAINED A PORTION OF THE TIP. I HAD A SUBSEQUENT CONVERSATION WITH THE DOCTOR AND THE PAIN NURSE. THE PATIENT WAS IN FACT OK. THE DOCTOR SAID THE EPIDURAL INSERTION WAS SMOOTH AND WHEN HE WENT TO INJECT THE TEST DOSE, HE NOTICED A LEAK AT THE SKIN (10CM MARK OF THE CATHETER). UPON FURTHER INSPECTION HE NOTICED THAT THE CATHETER APPEARED TO BE SEVERED. DECIDED TO REMOVE THE CATHETER AND PLACE A NEW ONE. WHEN HE TRIED TO REMOVE THE CATHETER, IT CAME APART WITH A GENTLE PULL AND THE REMAINING DISTAL 10 CM REMAINED IN THE PATIENTS BACK (POLYURETHANE AND COIL). THE DOCTOR STATED THAT IT APPEARED AS IF THE CATHETER HAD BEEN SEVERED. HE WAS ABLE TO REMOVE THE COIL. NO INTERVENTION WAS PERFORMED. WE CONSULTED WITH NEURO/ORTHOPEDIC SPINE SURGEON WHO SAID NOT TO INTERVENE UNLESS IN THE FUTURE A PROBLEM ARISES. SPOKE WITH THE PATIENT AND FAMILY AT LENGTH TO FOLLOW UP IF ANY ISSUES ARISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569289 ↗

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-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-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
• Z-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN