ARROW IPN919630Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902189315), received between Mar 8, 2022 and Apr 26, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "AN ANESTHESIA PROVIDER PUT AN EPIDURAL IN A OB PATIENT ON SUNDAY AND THE CATHETER WOULD NOT FLUSH. HE TRIED TO TROUBLESHOOT IT AND REPLACE THE SYRINGE SNAPLOCK BUT END UP REPLACING THE WHOLE CATHETER. EVEN WHEN HE TOOK IT OUT OF THE PATIENT HE STILL COULDN'T GET IT TO FLUSH". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "OK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16819178 ↗
• MalfunctionFeb 21, 2023Break; Break

  REPORTED ISSUE: NEEDLE BROKE IN THE PATIENT'S BACK. IT WAS REMOVED BY THE ANESTHESIOLOGIST AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409723 ↗
• MalfunctionJan 29, 2023Material Separation; Material Separation

  REPORTED EVENT: YESTERDAY WE HAD AN INCIDENT WITH AN EPIDURAL CATHETER THAT BROKE AN HOUR OR SO AFTER PLACEMENT. THE ISSUE WAS NOTED WHEN THE PATIENT WAS NOT FEELING RELIEF FROM HER EPIDURAL. UPON INVESTIGATION, THE EPIDURAL CATHETER WAS BROKEN APPROXIMATELY TWO FEET FROM THE TIP. THE ANESTHESIOLOGIST REPAIRED THE TUBING BY CUTTING THE END AND SECURING A NEW BLUE CAP TO THE END AND RECONNECTED TO THE INFUSION TUBING THROUGH THE EPIDURAL PUMP USING ASEPTIC TECHNIQUE. NO HARM TO THE PATIENT OCCURRED. THE CATHETER WAS SECURED USING TEGADERM AND IT HAD BEEN IN USE FOR 18 HOURS IN A PATIENT WHO WAS NOT AMBULATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261701 ↗
• InjuryAug 17, 2022Separation Problem; Separation Problem

  CUSTOMER STATES EPIDURAL PLACED 7/17 AROUND 0800. ON 7/18 AROUND 1600 , RESIDENT ATTEMPTED TO PULL EPIDURAL BUT ENCOUNTERED RESISTANCE WHILE PULLING. THEN NOTED EPIDURAL WIRE HAD COME UNWOUND AROUND 7CM AND ONLY SMALL PIECES OF THE WIRE REMAINED CONNECTED TO UNDERLYING CATHETER. ATTENDING ATTEMPTED TO REMOVE. WIRE BROKE OFF, ESTIMATED ROUGHLY 7-7CM OF THE CATHETER RETAINED UNDER THE SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15239596 ↗
• MalfunctionJul 11, 2022Material Puncture/Hole; Material Puncture/Hole

  ARROW EPIDURAL CATH THAT HAD A RANDOM HOLE IN IT (IDENTIFIED AFTER PATIENT ALREADY HAD CATHETER IN HER BACK), SO EPIDURAL CATHETER HAD TO BE REPLACED. THERE WAS NO PATIENT HARM/INJURY/CONSEQUENCE. THE PATIENT IS REPORTED TO BE FINE. THERE WAS A DELAY/INTERRUPTION IN TREATMENT. IT IS UNKNOWN IF THE PATIENT WAS EXPOSED TO INFECTIOUS DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982457 ↗
• MalfunctionJun 28, 2022Difficult to Remove; Difficult to Remove

  FLEXTIP PLUS BROKE IN PATIENT UPON TRYING TO REMOVE. NURSING CALLED ANESTHESIA DUE TO THE DIFFICULTY REMOVING. PATIENT DESCRIBED AS MORBIDLY OBESE. THEY TRIED ALL THE SUGGESTED WAYS TO GET CATHETER TO FREE UP, NOTHING WORKED. FINALLY WENT TO FLOURO TO LOOK AT CATHETER AND DECIDED TO HOLD ONTO THE CATHETER AND HELD IT AT THE SKIN (NOT PULLING) WITH TENSION AND THE CATHETER BROKE SOMEWHERE BELOW THE 5CM MARKING AND 3CM. TALKED TO SPINE SURGEON IN COLUMBIA, SC WHO SAID TO LEAVE THE REMAINING CATHETER IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844065 ↗
• MalfunctionMar 8, 2022Break; Break

  TWO CATHETERS BROKE APART AND 4.3CM REMAINS IN THE PATIENTS BACK. ADDITIONAL INFORMATION: IT HAPPENED WITH DIFFERENT PATIENTS AROUND THE SAME TIME.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 13693330 ↗
• MalfunctionMar 8, 2022Break; Break

  TWO CATHETERS BROKE APART AND 4.3CM REMAINS IN THE PATIENTS BACK. ADDITIONAL INFORMATION: IT HAPPENED WITH DIFFERENT PATIENTS AROUND THE SAME TIME.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 13693019 ↗

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-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-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
• Z-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN