ARROW IPN045729Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902114430), received between Jun 19, 2020 and Jul 31, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "THERE HAVE BEEN 2 INSTANCES WHERE THE NEEDLE IN THE EPIDURAL KITS USED TO INJECT LOCAL HAS BROKEN OFF. BOTH KITS HAVE THE SAME LOT NUMBER."

  Patient problems: Insufficient Information

  MAUDE report 22673629 ↗
• MalfunctionJul 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "THERE HAVE BEEN 2 INSTANCES WHERE THE NEEDLE IN THE EPIDURAL KITS USED TO INJECT LOCAL HAS BROKEN OFF. BOTH KITS HAVE THE SAME LOT NUMBER."

  Patient problems: Insufficient Information

  MAUDE report 22673598 ↗
• MalfunctionSep 15, 2021Leak/Splash

  LARGE LEAK NOTED IN EPIDURAL CATHETER PROXIMAL TO SNAP-LOCK ADAPTER, AFTER TEST DOSE ADMINISTERED. CATHETER REMOVED W/O INJURY TO PT. ANOTHER KIT OPENED AND SUCCESSFULLY ADMINISTERED EPIDURAL W/O DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12473746 ↗
• MalfunctionMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER STATING CATHETER IS LEAKING MEDICATION ONCE PLACED IN EPIDURAL SPACE NEGATIVELY IMPACTED PATIENT STABILITY AND STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399244 ↗
• MalfunctionMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER STATING CATHETER IS LEAKING MEDICATION ONCE PLACED IN EPIDURAL SPACE NEGATIVELY IMPACTED PATIENT STABILITY AND STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399222 ↗
• MalfunctionMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER STATING CATHETER IS LEAKING MEDICATION ONCE PLACED IN EPIDURAL SPACE NEGATIVELY IMPACTED PATIENT STABILITY AND STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399219 ↗
• MalfunctionJun 19, 2020Flushing Problem

  INCIDENT DESCRIPTION: THE EPIDURAL WAS PLACED BY CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA). ONCE THE EPIDURAL CATHETER WAS IN PLACE, THE CATHETER WAS NOT PATENT AND UNABLE TO BE FLUSHED OR HAVE TEST DOSE ADMINISTERED. CONNECTOR CHANGED BY CRNA AND THERE WAS STILL NO SUCCESS IN FLUSHING THE EPIDURAL CATHETER. EPIDURAL CATHETER WAS REMOVED AND THERE WERE NO KINKS OR KNOTS NOTED IN THE CATHETER. A NEW CATHETER WAS THEN PLACED AND FLUSHED SUCCESSFULLY. THE PATIENT WAS NOT HARMED AND HAD A FUNCTIONAL EPIDURAL ON THE SECOND ATTEMPT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173353 ↗

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