ARROW IPN046728Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902014160), received between Jun 4, 2024 and Jun 4, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "TWICE IN THE LAST MONTH, THE CATHETER FROM THIS KIT HAS BROKEN OFF WHEN BEING PULLED OUT/DISCONTINUED. WITH THE MOST RECENT OCCURRENCE (LAST THURSDAY), THE CATHETER AND THE INTERNAL WIRE BROKE OFF. THESE PATIENTS NEEDED TO HAVE SURGERY TO HAVE THE REMAINING PART OF THE CATHETER RETRIEVED FROM THEIR BACKS." ADDITIONAL INFORMATION REPORTS "THE PATIENT WAS CONSULTED WITH THE NEURO SURGERY TEAM AND HD TO GO BACK TO THE OPERATING ROOM TO HAVE THE REMAINDER OF THE CATHETER REMOVED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2024-00523.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459850 ↗
• InjuryJun 4, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "TWICE IN THE LAST MONTH, THE CATHETER FROM THIS KIT HAS BROKEN OFF WHEN BEING PULLED OUT/DISCONTINUED. WITH THE MOST RECENT OCCURRENCE (LAST THURSDAY), THE CATHETER AND THE INTERNAL WIRE BROKE OFF. THESE PATIENTS NEEDED TO HAVE SURGERY TO HAVE THE REMAINING PART OF THE CATHETER RETRIEVED FROM THEIR BACKS." ADDITIONAL INFORMATION REPORTS "THE PATIENT WAS CONSULTED WITH THE NEURO SURGERY TEAM AND HD TO GO BACK TO THE OPERATING ROOM TO HAVE THE REMAINDER OF THE CATHETER REMOVED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2024-00524.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459812 ↗
• MalfunctionJun 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "TWICE IN THE LAST MONTH, THE CATHETER FROM THIS KIT HAS BROKEN OFF WHEN BEING PULLED OUT/DISCONTINUED. WITH THE MOST RECENT OCCURRENCE LAST THURSDAY, THE CATHETER AND THE INTERNAL WIRE BROKE OFF. THE PATIENTS WERE CONSULTED WITH THE NEURO SURGERY TEAM AND HAD TO GO BACK TO THE OPERATING ROOM TO HAVE THE REMAINDER OF THE CATHETER REMOVED." ASSOCIATED COMPLAINTS: 9680794-2024-00524, 9680794-2024-00523 AND 9680794-2024-00525.

  Patient problems: Foreign Body In Patient

  MAUDE report 19456788 ↗

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-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-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
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC