ARROW IPN045606Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 40801902005128), received between Aug 31, 2020 and Nov 11, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "EPIDURAL SPINAL CATHETER WHICH IS BROKEN 3 CM BELOW THE SKIN SURFACE. THE BROKEN CATHETER TIP IS AT THE INTERSPINOUS SPACE OF L3-4. THE PATIENT UNDERWENT A RIGHT LAMINOTOMY AND REMOVAL OF RETAINED EPIDURAL CATHETER." ASSOCIATED COMPLAINTS: 9680794-2025-00939.

  Patient problems: Foreign Body In Patient

  MAUDE report 23520195 ↗
• InjuryNov 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "DURING THE EPIDURAL CATHETER REMOVAL SEGMENT OF THE CATHETER WAS RETAINED. CT SCAN - THE IMAGES SHOW BROKEN EPIDURAL CATHETER IN THE RIGHT-SIDE SPINAL CANAL OUTSIDE OF THE THECAL SAC AT L3-4 EXTENDING TO THE SUBCUTANEOUS FAT 5 CM FROM THE SKIN SURFACE. THE PATIENT HAS A SCHEDULED PRE-SURGERY APPOINTMENT WITH THE NEUROSURGEON THIS MONTH."

  Patient problems: Foreign Body In Patient

  MAUDE report 23494671 ↗
• InjuryAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "NURSE REMOVED EPIDURAL CATHETER ON (B)(6), UNAWARE THAT PART OF THE CATHETER WAS STILL IN THE PATIENT. FAST FORWARD A COUPLE WEEKS LATER, WITH A COUPLE INSTANCES OF THE PATIENT CALLING IN FOR BACK PAIN AND SHE DID HAVE SOME PARESTHESIAS IN HER LOWER EXTREMITIES. THE PATIENT NEEDED A STAT CT FOR IMAGING, TO FIND OUT EXACTLY WHAT PART WAS LEFT INSIDE, AND THEN NEEDED EMERGENCY LAMINECTOMY, FOREIGN BODY REMOVAL. FOR THE PROCEDURE, SHE NEEDED GENERAL ANESTHESIA, INTUBATION, MEDICATIONS FOR THE PROCEDURE ITSELF, ADDITIONAL PAIN MEDICATION AND THEN NEUROSURGICAL OBSERVATION DURING HER ADMISSION. PATIENT HAS RECOVERED AND IS AT HOME, AFTER DELIVERY AND HER EMERGENCY SURGERY. SHE'S BEING FOLLOWED UP BY OBSTETRICS AND NEUROSURGERY."

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 22793745 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "CATHETER LEAKED WHILE ADMINISTERING DRUGS FOR ADDUCTOR CANAL BLOCK. THERE WAS NO REPORTED PATIENT HARM OR CON SEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409436 ↗
• MalfunctionDec 20, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT: "ANESTHESIOLOGIST WAS NOT ABLE TO PASS THE CATHETER THROUGH THE EPIDURAL NEEDLE. SHE REMOVED THE CATHETER AND NOTICED THE WIRE REINFORCED SMALL SPRING INSIDE WAS BROKEN INTO PIECES INSIDE THE CATHETER. NO PATIENT INJURY OCCURRED. CATHETER WAS REMOVED AND A COMPETITIVE CATHETER WAS SUCCESSFULLY PLACED." THERE WAS NO PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 9680794-2024-01257, 9680794-2024-01258 AND 9680794-2024-01259.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986326 ↗
• MalfunctionDec 20, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT: "ANESTHESIOLOGIST WAS NOT ABLE TO PASS THE CATHETER THROUGH THE EPIDURAL NEEDLE. SHE REMOVED THE CATHETER AND NOTICED THE WIRE REINFORCED SMALL SPRING INSIDE WAS BROKEN INTO PIECES INSIDE THE CATHETER. NO PATIENT INJURY OCCURRED. CATHETER WAS REMOVED AND A COMPETITIVE CATHETER WAS SUCCESSFULLY PLACED." THERE WAS NO PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 9680794-2024-01257, 9680794-2024-01258, 9680794-2024-01259.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986148 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE INTERNAL WIRE IN THE EPIDURAL CATHETER IS KINKING / BINDING UP WHEN TRYING TO PUSH THROUGH THE NEEDLE CAUSING THEM TO USE MULTIPLE CATHETERS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624007 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE INTERNAL WIRE IN THE EPIDURAL CATHETER IS KINKING / BINDING UP WHEN TRYING TO PUSH THROUGH THE NEEDLE CAUSING THEM TO USE MULTIPLE CATHETERS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623962 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE INTERNAL WIRE IN THE EPIDURAL CATHETER IS KINKING / BINDING UP WHEN TRYING TO PUSH THROUGH THE NEEDLE CAUSING THEM TO USE MULTIPLE CATHETERS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623939 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE INTERNAL WIRE IN THE EPIDURAL CATHETER IS KINKING / BINDING UP WHEN TRYING TO PUSH THROUGH THE NEEDLE CAUSING THEM TO USE MULTIPLE CATHETERS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623867 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE INTERNAL WIRE IN THE EPIDURAL CATHETER IS KINKING / BINDING UP WHEN TRYING TO PUSH THROUGH THE NEEDLE CAUSING THEM TO USE MULTIPLE CATHETERS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623865 ↗
• MalfunctionMar 21, 2022Complete Blockage; Complete Blockage

  RAN INTO THIS ISSUE TODAY ON L & D. EPIDURAL CATHETER WAS SEALED AT THE PROXIMAL END. ADDITIONAL INFORMATION: THE CATHETER HAD ALREADY BEEN INSERTED INTO THE PATIENT. BECAUSE THE DEFECT WAS THE END DISTAL TO THE PATIENT IT WAS NOT DISCOVERED UNTIL THE TUOCHY NEEDLE WAS REMOVED AND SOMETHING CAUGHT AS THE CATHETER PASSED THROUGH THE LUMEN. I ENDED UP TAKING STERILE SCISSORS AND CUTTING OFF THE SEALED PORTION WHICH ALLOWED THE CATHETER TO FUNCTION AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839474 ↗
• MalfunctionDec 13, 2021Complete Blockage; Complete Blockage

  I HAD AN EPIDURAL KIT WITH AN EPIDURAL CATHETER WITH THE TIP STILL SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983548 ↗
• InjuryAug 31, 2020Material Separation; Physical Resistance/Sticking

  PER ANESTHESIOLOGIST, ATTEMPT AT L4/5, OS AT MULTIPLE ANGLES BEFORE LOR (LOSS OF RESISTANCE), UNABLE TO THREAD CATHETER SMOOTHLY. CONSIDERED THIN EPIDURAL SPACE AT THAT LEVEL NOT SUITABLE FOR EPIDURAL CATHETER. ATTEMPT AT L3/4, OS AT MULTIPLE ANGLES BEFORE LOR, AGAIN UNABLE TO THREAD CATHETER SMOOTHLY. ATTEMPT AT L5/S1, LOR AT 7 CM, EPIDURAL CATHETER ADVANCED SMOOTHLY INTO EPIDURAL SPACE. RESISTANCE WHEN RETRIEVING NEEDLE, STOPPED PULLING IMMEDIATELY ON NEEDLE, AND DECIDED TO PULL NEEDLE AND EPIDURAL CATHETER TOGETHER. WHEN NEEDLE REMOVED, SAW EXPOSED INNER WIRE FROM CATHETER. PULLED ALL OF WIRE OUT. COMPARED PULLED CATHETER TO NEW CATHETER AND NOTED APPROXIMATELY 5 CM OF CATHETER PRESUMED TO REMAIN IN EPIDURAL SPACE. PATIENT DENIED PARAESTHESIAS OR NEUROLOGICAL SYMPTOMS DURING ALL THE ATTEMPTS AND AFTER REMOVAL OF CATHETER. ANOTHER CATHETER WAS PLACED WITHOUT COMPLICATION. PATIENT UNDERWENT CESAREAN SECTION WITHOUT COMPLICATION. NEUROSURGEON CONSULTED. CT SCAN ORDER OF THE LUMBAR SPINE TO DETERMINE THE POSITION OF THE RETAINED CATHETER FRAGMENT. CT SCAN CONFIRMED PRESENCE OF RETAINED CATHETER AT THE L4-5 LEVEL, APPEARED TO BE EPIDURAL, LEFT SIDE EXTENDING INTO THE PROXIMAL PORTION

  Patient problems: Foreign Body In Patient

  MAUDE report 10471035 ↗