ARROW IPN920769Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902197631), received between Nov 28, 2022 and Jul 8, 2026 — 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 8, 2026Material Separation

  IT WAS REPORTED THAT "TUOHY NEEDLE GRIP: THE WINGS ARE SMALLER THAN EXPECTED AND DO NOT ENSURE A SECURE AND STABLE GRIP DURING HANDLING." NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25756670 ↗
• MalfunctionApr 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2026, WHEN THE NEEDLE WAS IN POSITION, THE CATHETER COULD NOT BE INSERTED, NEEDLE BENT. A CATHETER FROM ANOTHER EPIDURAL KIT OF A DIFFERENT BRAND, WHICH WAS MORE RIGID, WAS USED AND INSERTED SUCCESSFULLY. WHEN WE REMOVED THE NEEDLE, WE OBSERVED IT WAS BENT. CONSEQUENCE FOR THE PATIENT: MULTIPLE PUNCTURES. NO OTHER HARM OR HEALTH CONSEQUENCES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764910 ↗
• MalfunctionMar 13, 2026Use of Device Problem; Material Twisted/Bent

  IT WAS REPORTED THAT "NO SENSATION OF PASSING THROUGH THE LIGAMENTS AND NEEDLES THAT BEND EASILY. IT DIFFICULT TO KNOW WHICH STRUCTURES WE ARE PASSING THROUGH AND THEREFORE TO ADMINISTER EPIDURALS SAFELY. THERE WERE SEVERAL PUNCTURES MADE ON THE SAME PATIENT AND THE EPIDURAL HAD NO EFFECT DURING DELIVERY. ANOTHER DEVICE WAS NEEDDED TO COMPLETE PROCEDURE."

  Patient problems: Inadequate Pain Relief

  MAUDE report 24588797 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT: "AFTER PLACEMENT OF THE EPIDURAL CATHETER, DURING THE LABOR PROCEDURE, THE LEAKAGE OF A FEW DROPS OF CEREBROSPINAL FLUID DUE TO A DURAL PUNCTURE WAS OBSERVED. AFTER DELIVERY, THE PATIENT WAS PLACED IN A SUPINE POSITION AND ADMINISTERED ANALGESIC THERAPY. IN ADDITION, THROMBOPROPHYLAXIS WITH SODIUM ENOXAPARIN WAS PROVIDED DUE TO BED REST. THE PATIENT WAS DISCHARGED ON THE THIRD DAY WITHOUT PRESENTING SYMPTOMS OF DURAL PUNCTURE, WITH INSTRUCTIONS TO RETURN TO THE EMERGENCY DEPARTMENT IN CASE OF HEADACHE. TO DATE, THE PATIENT HAS NOT RETURNED TO THE EMERGENCY DEPT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302476 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT: "AFTER PLACEMENT OF THE EPIDURAL CATHETER, DURING THE LABOR PROCEDURE, THE LEAKAGE OF A FEW DROPS OF CEREBROSPINAL FLUID DUE TO A DURAL PUNCTURE WAS OBSERVED. AFTER DELIVERY, THE PATIENT WAS PLACED IN A SUPINE POSITION AND ADMINISTERED ANALGESIC THERAPY. IN ADDITION, THROMBOPROPHYLAXIS WITH SODIUM ENOXAPARIN WAS PROVIDED DUE TO BED REST. THE PATIENT WAS DISCHARGED ON THE THIRD DAY WITHOUT PRESENTING SYMPTOMS OF DURAL PUNCTURE, WITH INSTRUCTIONS TO RETURN TO THE EMERGENCY DEPARTMENT IN CASE OF HEADACHE. TO DATE, THE PATIENT HAS NOT RETURNED TO THE EMERGENCY DEPT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302455 ↗
• MalfunctionJan 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT: "THE CATHETER WAS INSERTED AND DURING THE INFUSION OF THE ANALGESIC. THE DEVICE LEAKED AT THE LEVEL OF THE CATHETER. THE LEAK WAS 0.5 CM ON THE OPPOSITE SIDE OF THE SNAPLOCK. THERE WAS NO CONSEQUENCE FOR THE PATIENT, PATIENT IS FINE. THE DEVICE WAS CHANGED. NO OTHER MEDICAL INTERVENTION NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066336 ↗
• MalfunctionNov 28, 2022Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  REPORTED ISSUE: INCIDENT OCCURRED ON (B)(6) 2022. THE EPIDURAL ANALGESIA CATHETER WAS INSERTED IN THE FEMALE PATIENT THAT WAS GIVING BIRTH. INSERTION DONE WITHOUT ANY DIFFICULTY. THE CATHETER WAS ATTACHED AS USUAL WITH A TRANSPARENT STERILE DRESSING AT THE LEVEL OF THE LUMBAR PUNCTURE BRIDGE AND ATTACHED TO THE PATIENT'S SHOULDER WITH A MEFIX-TYPE DRESSING. THE PATIENT WAS NOT AGITATED, SHE WAS NOT RUBBING HER BACK EXCESSIVELY ON THE BED. OBSERVING THE INEFFICIENCY OF THE EPIDURAL ANALGESIA 5 HOURS AFTER INSERTION, THE MIDWIFE EXAMINED THE PUNCTURE SITE SEARCHING FOR A POSSIBLE LEAK FROM THE CATHETER. SHE DISCOVERED A CUT OF THE CATHETER 30 CM FROM THE TIP THAT IS INSIDE PATIENT. I REMOVED THE CATHETER AND INSERTED A NEW ANALGESIA CATHETER. THERE WAS LOSS OF ANALGESIA AND PATIENT DISCOMFORT BUT NO PART OF THE CATHETER WAS LEFT IN THE PATIENT, NO BREACH.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 15868591 ↗

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-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-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