ARROW IPN040153Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902139679), received between Aug 12, 2021 and Feb 23, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2022Material Fragmentation; Material Too Soft/Flexible; Material Fragmentation; Material Too Soft/Flexible

  IT SEEMS THAT THE CATHETER IS VERY ELASTIC UNTIL YOU REACH THE MARKINGS THEN IT IS BRITTLE AND BREAKS WHEN PULLED. IT CAN BE REPEATED WITH OTHER CATHETERS THAT WERE NOT USED ON A PATIENT. I BELIEVE TWO PATIENTS, YES STANDARD EPIDURALS FOR OR SURGERY, NO INJURY THUS FAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586849 ↗
• MalfunctionFeb 23, 2022Material Fragmentation; Material Too Soft/Flexible; Material Fragmentation; Material Too Soft/Flexible

  IT SEEMS THAT THE CATHETER IS VERY ELASTIC UNTIL YOU REACH THE MARKINGS THEN IT IS BRITTLE AND BREAKS WHEN PULLED. IT CAN BE REPEATED WITH OTHER CATHETERS THAT WERE NOT USED ON A PATIENT. I BELIEVE TWO PATIENTS, YES STANDARD EPIDURALS FOR OR SURGERY, NO INJURY THUS FAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586785 ↗
• MalfunctionJan 10, 2022No Flow; No Flow

  EPIDURAL CATHETER WAS INSERTED SUCCESSFULLY BY ANESTHETIST ON CALL. THE ANESTHETIST THEN PLACED THE SYRINGE ADAPTER ON THE END OF THE CATHETER AND PROCEEDED TO INSTILL THE MEDICATION BUT WAS UNABLE TO PUSH ANY MEDICATION INTO THE EPIDURAL CATHETER. THE DOCTOR REMOVED THE CATHETER AND WAS STILL UNABLE TO PUSH ANY MEDICATION INTO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206717 ↗
• MalfunctionOct 4, 2021Failure to Advance; Failure to Advance

  INTERMITTENTLY, WE HAVE HAD SOME ISSUES WITH PASSING THE ARROW CATHETERS THROUGH THE PERIPHERAL NERVE BLOCK TRAY TUOHY. THE ARROW CATHETERS HAVE BEEN REPORTED TO ME AS BEING FLIMSIER THAN PREVIOUSLY. SEEMS TO REACH A WEAK POINT AT 13-15 CM. WE HAD AN ISSUE PASSING THE CATHETER, CHANGED THEN CATHETER (DID NOT HELP) THEN WE CHANGED THE TUOHY (I PULLED A SEPARATE STERILE TUOHY), AND IT WAS OK. I ALSO JUST HEARD THAT ABOUT 1 WEEK AGO THE CATHETER COULD NOT PASS AND WOULD NOT PULL OUT OF THE TUOHY, SO THE ENTIRE NEEDLE AND CATHETER WAS REMOVED TOGETHER. JUST WANTED TO REPORT THAT THIS HAS BEEN OCCURRING FOR SOME OF THE DOCTORS. I WILL SAVE THE ACTUAL SUPPLIES IF THIS OCCURS AGAIN, BUT I DID GET LOT NUMBERS OUT OF THE GARBAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568392 ↗
• MalfunctionOct 4, 2021Failure to Advance; Failure to Advance

  INTERMITTENTLY, WE HAVE HAD SOME ISSUES WITH PASSING THE ARROW CATHETERS THROUGH THE PERIPHERAL NERVE BLOCK TRAY TUOHY. THE ARROW CATHETERS HAVE BEEN REPORTED TO ME AS BEING FLIMSIER THAN PREVIOUSLY. SEEMS TO REACH A WEAK POINT AT 13-15 CM. WE HAD AN ISSUE PASSING THE CATHETER, CHANGED THEN CATHETER (DID NOT HELP) THEN WE CHANGED THE TUOHY (I PULLED A SEPARATE STERILE TUOHY), AND IT WAS OK. I ALSO JUST HEARD THAT ABOUT 1 WEEK AGO THE CATHETER COULD NOT PASS AND WOULD NOT PULL OUT OF THE TUOHY, SO THE ENTIRE NEEDLE AND CATHETER WAS REMOVED TOGETHER. JUST WANTED TO REPORT THAT THIS HAS BEEN OCCURRING FOR SOME OF THE DOCTORS. I WILL SAVE THE ACTUAL SUPPLIES IF THIS OCCURS AGAIN, BUT I DID GET LOT NUMBERS OUT OF THE GARBAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568377 ↗
• MalfunctionAug 16, 2021No Flow; No Flow

  WE FOUND ANOTHER OCCLUDED OPEN END HOLE TYPE CATHETER THIS AM WHEN PERFORMING ERECTOR SPINAE BLOCKS. THE LOT NUMBER IS 71F20L2033 IT IS IN MY POSSESSION. TO MY KNOWLEDGE THERE WAS NO HARM TO THE PATIENT EXCEPT THAT PRESENTED BY THE NEED TO PERFORM A SECOND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325366 ↗
• MalfunctionAug 12, 2021Failure to Advance; Failure to Advance

  THERE WAS A DEFECTIVE TIP ON THE ARROW CATHETER LOT 12551654. THEY COULD NOT THREAD IT DUE TO THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313430 ↗

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