ARROW IPN056376Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902162486), received between Jan 28, 2021 and Mar 30, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2022No Flow; No Flow

  UNFORTUNATELY, WE'VE DISCOVERED ANOTHER CATHETER THAT IS NOT PATENT. I HAVE IT IN MY OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955732 ↗
• MalfunctionAug 12, 2021No Flow; No Flow

  TODAY, AFTER PLACING A LABOR EPIDURAL WHILE TRYING TO TEST DOSE THE CATHETER I WAS UNABLE TO PUSH THE TEST DOSE THROUGH THE CATHETER. THAT CATHETER HAD TO BE REMOVED AND AGAIN WHILE INSPECTING THE CATHETER TIP I WAS UNABLE TO PUSH ANY FLUID THROUGH THE CATHETER. TO MY UNAIDED EYE THERE WERE NO MICRO PERFORATIONS AT THE TIP OF THIS CATHETER. A SECOND KIT WAS OBTAINED AND PRIOR TO EPIDURAL NEEDLE PLACEMENT THE CATHETER WAS TESTED AND HAD THE EXPECTED MICRO PERFORATIONS AT THE TIP. THE DEFECTIVE CATHETER WAS SET ASIDE TO BE RETURNED TO THE MANUFACTURER. THE FOLLOWING WAS FROM A FOLLOW-UP CONVERSATION WITH THE ATTENDING PHYSICIAN: THE PATIENT HAD AN EXISTING EPIDURAL WHICH PROVIDED A ONE-SIDED BLOCK AND THEREFORE WAS BEING REPLACED. AFTER PLACING THE SECOND CATHETER IN THE EPIDURAL SPACE AND REMOVING THE EPIDURAL NEEDLE AND THEN TEST-DOSING THE CATHETER I WAS UNABLE TO PUSH ANY MEDICATION THROUGH THE SECOND CATHETER. THAT CATHETER WAS PULLED, NECESSITATING THE PLACEMENT OF A THIRD CATHETER. THE SECOND CATHETER WAS INSPECTED AND ATTEMPTED TO BE FLUSHED AGAIN AFTER BEING REMOVED FROM THE PATIENT BUT EVEN WITH EXTREME PRESSURE BEING APPLIED TO THE ATTACHED SYRINGE, I WAS UNABLE TO GET ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313654 ↗
• MalfunctionAug 12, 2021No Flow; No Flow

  TODAY, AFTER PLACING A LABOR EPIDURAL WHILE TRYING TO TEST DOSE THE CATHETER I WAS ABSOLUTELY UNABLE TO PUSH THE TEST DOSE THROUGH THE CATHETER. THAT CATHETER HAD TO BE REMOVED AND AGAIN, WHILE INSPECTING THE CATHETER TIP I WAS UNABLE TO PUSH ANY FLUID THROUGH THE CATHETER. TO MY UNAIDED EYE THERE WERE NO MICRO PERFORATIONS AT THE TIP OF THIS CATHETER. A SECOND KIT WAS OBTAINED AND PRIOR TO EPIDURAL NEEDLE PLACEMENT THE CATHETER WAS TESTED AND HAD THE EXPECTED MICRO PERFORATIONS AT THE TIP. THE DEFECTIVE CATHETER WAS SET ASIDE TO BE RETURNED TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313582 ↗
• MalfunctionJan 28, 2021No Flow; No Flow

  CATHETER WAS OCCLUDED; WOULD NOT ALLOW THE FLOW OF MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11245996 ↗

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-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