ARROW IPN919609Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10801902189117), received between Feb 9, 2022 and Mar 27, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Break; Difficult to Remove; Break; Difficult to Remove

  REPORTED ISSUE: EPIDURAL CATHETER PLACED IN PATIENT WITH NO INCIDENT. UPON REMOVAL, THE CATHETER SHEARED IN TWO AND SOME OF THE EPIDURAL REMAINED IN PATIENT. THERE WERE NO COMPLICATIONS AND DUE TO THE PATIENT'S AGE NO REMOVAL OF THE BROKEN PART WAS PERFORMED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620424 ↗
• MalfunctionMar 24, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: COULD NOT PASS FLEXTIP PLUS CATHETER THROUGH TUOHY NEEDLE. NO PATIENT INJURY OR CONSEQUENCE. THE CONDITION OF THE PATIENT WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613035 ↗
• MalfunctionMar 15, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: THE SPINAL NEEDLE WAS REMOVED, AND THE EPIDURAL CATHETER WAS ATTEMPTED TO BE THREADED. IT WOULD NOT ADVANCE BEYOND THE TIP OF THE NEEDLE. AFTER MULTIPLE EFFORTS TO THREAD THE CATHETER THE CATHETER GAVE A POP SENSATION, AND THEN THREADED. THE CATHETER FELT SNUG IN THE TUOHY NEEDLE WHEN THE TUOHY NEEDLE WAS REMOVED. A CLOSE-UP PHOTOGRAPH OF THE TIP OF THE EPIDURAL NEEDLE WAS TAKEN AND THERE IS A LIP OF METAL THAT IS AT THE TIP OF THE NEEDLE ORIFICE FACING INWARD. THIS IS WHAT THE CATHETER WAS CATCHING ON IN OUR ATTEMPT TO ADVANCE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545196 ↗
• MalfunctionMar 15, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: THE SPINAL NEEDLE WAS REMOVED, AND THE EPIDURAL CATHETER WAS ATTEMPTED TO BE THREADED. IT WOULD NOT ADVANCE BEYOND THE TIP OF THE NEEDLE. AFTER MULTIPLE EFFORTS TO THREAD THE CATHETER THE CATHETER GAVE A POP SENSATION, AND THEN THREADED. THE CATHETER FELT SNUG IN THE TUOHY NEEDLE WHEN THE TUOHY NEEDLE WAS REMOVED. A CLOSE-UP PHOTOGRAPH OF THE TIP OF THE EPIDURAL NEEDLE WAS TAKEN AND THERE IS A LIP OF METAL THAT IS AT THE TIP OF THE NEEDLE ORIFICE FACING INWARD. THIS IS WHAT THE CATHETER WAS CATCHING ON IN OUR ATTEMPT TO ADVANCE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545158 ↗
• MalfunctionMar 14, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: THE SPINAL NEEDLE WAS REMOVED, AND THE EPIDURAL CATHETER WAS ATTEMPTED TO BE THREADED. IT WOULD NOT ADVANCE BEYOND THE TIP OF THE NEEDLE. AFTER MULTIPLE EFFORTS TO THREAD THE CATHETER THE CATHETER GAVE A POP SENSATION, AND THEN THREADED. THE CATHETER FELT SNUG IN THE TUOHY NEEDLE WHEN THE TUOHY NEEDLE WAS REMOVED. A CLOSE-UP PHOTOGRAPH OF THE TIP OF THE EPIDURAL NEEDLE WAS TAKEN AND THERE IS A LIP OF METAL THAT IS AT THE TIP OF THE NEEDLE ORIFICE FACING INWARD. THIS IS WHERE THE CATHETER WAS CATCHING ON IN OUR ATTEMPT TO ADVANCE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539302 ↗
• MalfunctionMar 14, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: THE SPINAL NEEDLE WAS REMOVED, AND THE EPIDURAL CATHETER WAS ATTEMPTED TO BE THREADED. IT WOULD NOT ADVANCE BEYOND THE TIP OF THE NEEDLE. AFTER MULTIPLE EFFORTS TO THREAD THE CATHETER THE CATHETER GAVE A POP SENSATION, AND THEN THREADED. THE CATHETER FELT SNUG IN THE TUOHY NEEDLE WHEN THE TUOHY NEEDLE WAS REMOVED. A CLOSE-UP PHOTOGRAPH OF THE TIP OF THE EPIDURAL NEEDLE WAS TAKEN AND THERE IS A LIP OF METAL THAT IS AT THE TIP OF THE NEEDLE ORIFICE FACING INWARD. THIS IS WHERE THE CATHETER WAS CATCHING ON IN OUR ATTEMPT TO ADVANCE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539273 ↗
• MalfunctionMar 14, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: THE SPINAL NEEDLE WAS REMOVED, AND THE EPIDURAL CATHETER WAS ATTEMPTED TO BE THREADED. IT WOULD NOT ADVANCE BEYOND THE TIP OF THE NEEDLE. AFTER MULTIPLE EFFORTS TO THREAD THE CATHETER THE CATHETER GAVE A POP SENSATION, AND THEN THREADED. THE CATHETER FELT SNUG IN THE TUOHY NEEDLE WHEN THE TUOHY NEEDLE WAS REMOVED. A CLOSE-UP PHOTOGRAPH OF THE TIP OF THE EPIDURAL NEEDLE WAS TAKEN AND THERE IS A LIP OF METAL THAT IS AT THE TIP OF THE NEEDLE ORIFICE FACING INWARD. THIS IS WHERE THE CATHETER WAS CATCHING ON IN OUR ATTEMPT TO ADVANCE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539214 ↗
• MalfunctionMar 14, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: THE SPINAL NEEDLE WAS REMOVED, AND THE EPIDURAL CATHETER WAS ATTEMPTED TO BE THREADED. IT WOULD NOT ADVANCE BEYOND THE TIP OF THE NEEDLE. AFTER MULTIPLE EFFORTS TO THREAD THE CATHETER THE CATHETER GAVE A POP SENSATION, AND THEN THREADED. THE CATHETER FELT SNUG IN THE TUOHY NEEDLE WHEN THE TUOHY NEEDLE WAS REMOVED. A CLOSE-UP PHOTO OF THE TIP OF THE EPIDURAL NEEDLE WAS TAKEN AND THERE IS A LIP OF METAL THAT IS AT THE TIP OF THE NEEDLE ORIFICE FACING INWARD. THIS IS WHERE THE CATHETER WAS CATCHING ON IN OUR ATTEMPT TO ADVANCE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539052 ↗
• MalfunctionMar 14, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: THE SPINAL NEEDLE WAS REMOVED, AND THE EPIDURAL CATHETER WAS ATTEMPTED TO BE THREADED. IT WOULD NOT ADVANCE BEYOND THE TIP OF THE NEEDLE. AFTER MULTIPLE EFFORTS TO THREAD THE CATHETER THE CATHETER GAVE A POP SENSATION, AND THEN THREADED. THE CATHETER FELT SNUG IN THE TUOHY NEEDLE WHEN THE TUOHY NEEDLE WAS REMOVED. A CLOSE-UP PHOTOGRAPH OF THE TIP OF THE EPIDURAL NEEDLE WAS TAKEN AND THERE IS A LIP OF METAL THAT IS AT THE TIP OF THE NEEDLE ORIFICE FACING INWARD. THIS IS WHAT THE CATHETER WAS CATCHING ON IN OUR ATTEMPT TO ADVANCE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538978 ↗
• MalfunctionMar 6, 2023Difficult to Advance; Difficult to Advance

  REPORTED ISSUE: PROBLEMS WITH THE EPIDURAL CATHETER THREADING THROUGH THE TUOHY NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488952 ↗
• MalfunctionJan 24, 2023Break; Break

  REPORTED EVENT: THE NEEDLE BROKE; IT OCCURRED IN A MANNER THAT ALLOWED FOR RETRIEVAL OF BOTH PARTS OF THE EPIDURAL NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233724 ↗
• MalfunctionJan 10, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WERE ISSUES PUSHING FLUIDS THROUGH THE CATHETER. THEY WERE UNABLE TO PUSH FLUIDS THOUGH THE CATHETER OR IT WAS VERY DIFFICULT. ADDITIONAL INFORMATION: THE 3 CATHETERS WERE USED ON 3 DIFFERENT PATIENTS DURING 3 DIFFERENT EVENTS. 2 WERE REPLACED WITH NEEDLE PUNCTURE AND 1 WAS NOT REPLACED DUE TO LACK OF TIME AND URGENCY OF THE SITUATION. THE PATIENT RECEIVED NITROUS OXIDE INSTEAD. THE CATHETERS WERE NOT TESTED FOR FLOW PRIOR TO PLACEMENT. TO DO SO REQUIRES SIGNIFICANT FORCE ON THE SNAPLOCK AND IS NOT ROUTINE CLINICAL PRACTICE. UNTIL THIS ISSUE IS FULLY INTERROGATED I HAVE TRANSITIONED TO CHECKING FLOW PRIOR TO PLACEMENT BUT THIS IS VERY MUCH NOT IDEAL AND NOT SOMETHING I WOULD RECOMMEND AS A LONG TERM SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16133083 ↗
• MalfunctionJan 10, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WERE ISSUES PUSHING FLUIDS THROUGH THE CATHETER. THEY WERE UNABLE TO PUSH FLUIDS THOUGH THE CATHETER OR IT WAS VERY DIFFICULT. ADDITIONAL INFORMATION: THE 3 CATHETERS WERE USED ON 3 DIFFERENT PATIENTS DURING 3 DIFFERENT EVENTS. 2 WERE REPLACED WITH NEEDLE PUNCTURE AND 1 WAS NOT REPLACED DUE TO LACK OF TIME AND URGENCY OF THE SITUATION. THE PATIENT RECEIVED NITROUS OXIDE INSTEAD. THE CATHETERS WERE NOT TESTED FOR FLOW PRIOR TO PLACEMENT. TO DO SO REQUIRES SIGNIFICANT FORCE ON THE SNAPLOCK AND IS NOT ROUTINE CLINICAL PRACTICE. UNTIL THIS ISSUE IS FULLY INTERROGATED I HAVE TRANSITIONED TO CHECKING FLOW PRIOR TO PLACEMENT BUT THIS IS VERY MUCH NOT IDEAL AND NOT SOMETHING I WOULD RECOMMEND AS A LONG TERM SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132983 ↗
• MalfunctionJan 10, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WERE ISSUES PUSHING FLUIDS THROUGH THE CATHETER. THEY WERE UNABLE TO PUSH FLUIDS THOUGH THE CATHETER OR IT WAS VERY DIFFICULT. ADDITIONAL INFORMATION: THE 3 CATHETERS WERE USED ON 3 DIFFERENT PATIENTS DURING 3 DIFFERENT EVENTS. 2 WERE REPLACED WITH NEEDLE PUNCTURE AND 1 WAS NOT REPLACED DUE TO LACK OF TIME AND URGENCY OF THE SITUATION. THE PATIENT RECEIVED NITROUS OXIDE INSTEAD. THE CATHETERS WERE NOT TESTED FOR FLOW PRIOR TO PLACEMENT. TO DO SO REQUIRES SIGNIFICANT FORCE ON THE SNAPLOCK AND IS NOT ROUTINE CLINICAL PRACTICE. UNTIL THIS ISSUE IS FULLY INTERROGATED I HAVE TRANSITIONED TO CHECKING FLOW PRIOR TO PLACEMENT BUT THIS IS VERY MUCH NOT IDEAL AND NOT SOMETHING I WOULD RECOMMEND AS A LONG TERM SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132958 ↗
• MalfunctionJul 25, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  TRAY WAS RIPPED OPEN AT A CORNER WHEN THEY RECEIVED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099348 ↗
• MalfunctionJun 8, 2022Break; Break

  THIS EPIDURAL KIT WAS OPENED AND CONTAINED AN OPEN, EMPTY GLASS AMPULE THAT SHOULD HAVE CONTAINED SALINE. THE SOLUTION APPEARED TO HAVE DRIED AND NOTHING WAS WET IN THE KIT. THIS IS A SHARPS ISSUE DUE TO THE OPENED GLASS AMPULES AND A QUALITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633133 ↗
• MalfunctionJun 6, 2022Break; Break

  THIS EPIDURAL KIT WAS OPENED AND CONTAINED AN OPEN, EMPTY GLASS AMPULE THAT SHOULD HAVE CONTAINED SALINE. THE SOLUTION APPEARED TO HAVE DRIED AND NOTHING WAS WET IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603880 ↗
• MalfunctionFeb 9, 2022Material Twisted/Bent; Material Twisted/Bent

  WE HAVE DEFINITELY SEEN AN INCREASE IN PROCEDURES WHERE WE HAVE DIFFICULTY THREADING. THIS IS MORE OFTEN THAN BEFORE. WHEN WE WOULD OCCASIONALLY SEE SOME DIFFICULTY GETTING THE CATHETER TOO PAST THE NEEDLE TIP. IN MANY RECENT CASES THE CATHETER APPEARS TO GET HUNG UP AT THE TIP, BUT INSTEAD OF BEING ABLE TO FINESSE IT THROUGH WE OFTEN SEE THE CATHETER KINK BADLY WITHIN THE TUOHY HUB, ESSENTIALLY SO THAT IT BUNCHES UP INSTEAD OF THREADS FORWARD. IN MY EXPERIENCES, ONCE WE SEE THAT BUNCHING IN THE TUOHY HUB IT IS IMPOSSIBLE TO ADVANCE THAT CATHETER BECAUSE BUNCHING UP IS ALL IT WILL DO FROM THEN ON. SWITCHING CATHETERS OFTEN SEEM TO FIX THE PROBLEM. THIS HAS LED MANY OF US TO BELIEVE THAT THE CURRENT BATCH OF ARROW CATHETERS ARE SOFTER OR HAVE A GREATER PROPENSITY TO KINK AND FOLD RATHER THAN THREAD FORWARD. SOME OF OUR ANESTHESIOLOGISTS HAVE MOVED AWAY FROM USING ARROW KITS FOR THIS REASON. THERE HAS BEEN DISCUSSION OF TAKING THE ISSUE TO THE SAFETY BOARD DUE TO HAVING AN OPEN PORT AND NEEDING TO REPLACE THE CATHETER WITH A NEW CATHETER DURING THE PROCEDURE. NO PRODUCT WAS OBTAINED AT THIS TIME BECAUSE THE ACCOUNT CLAIMS THIS HAPPENS OCCASIONALLY AND DID NOT HOLD PRODUCT. I HAVE DIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499817 ↗

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-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
• Z-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC