ARROW IPN046311 (REF JC-05400-B)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 40801902029674), received between Jan 28, 2021 and Oct 23, 2025 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 reports).

4 other recalls cover devices cleared under the same FDA submission (K103658); 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "THE SYRINGE TIP DOES NOT FIT INTO THE PUNCTURE NEEDLE, MAKING IT IMPOSSIBLE TO CHECK THE LOSS OF RESISTANCE. THIS MEANS THAT THE SET CANNOT BE USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367119 ↗
• MalfunctionOct 23, 2025Component or Accessory Incompatibility; Incomplete or Inadequate Connection; Component or Accessory Incompatibility; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT "THE SYRINGE TIP DOES NOT FIT INTO THE PUNCTURE NEEDLE, MAKING IT IMPOSSIBLE TO CHECK THE LOSS OF RESISTANCE. WE HAD TO REMOVE THE NEEDLE AND PUNCTURE AGAIN. THIS MEANS THAT THE SET CANNOT BE USED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Needle Stick/Puncture

  MAUDE report 23366200 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED THAT: "WE HAVE RECEIVED FEEDBACK FROM OUR ANAESTHETISTS REGARDING THE ARMOURED EPIDURAL SETS CONCERNING THE DIAMETER OF THE NEEDLE, WHICH SLIDES TOO EASILY (SMALLER DIAMETER?) AND BENDS MORE EASILY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299094 ↗
• MalfunctionApr 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT " NO LOSS OF RESISTANCE WITH THE SYRINGE PLUNGER. I CAN CONFIRM THE OCCURRENCE OF A BREACH WITH CLINICAL MANIFESTATIONS SUCH AS HEADACHE AND NECK PAIN. PATIENT DISCHARGED ON (B)(6) 2025. REQUIRED 3 BLOOD PATCHES ON (B)(6)."

  Patient problems: Pain

  MAUDE report 21805123 ↗
• MalfunctionMar 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING 10 ML WHILE SEARCHING FOR EPIDURAL SPACE CAUSING DURA MATTER BREACH. AFTER CHECKING THE LOR ON STOCK, IT WAS OBSERVED THAT THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING THE 10 ML. THIS CAUSED DELAY IN TREATMENT AND INCREASE COST DUE TO REPLACEMENT." ASSOCIATED COMPLAINTS 3006425876-2025-00180, 3006425876-2025-00181.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504860 ↗
• MalfunctionMar 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING 10 ML WHILE SEARCHING FOR EPIDURAL SPACE CAUSING DURA MATTER BREACH. AFTER CHECKING THE LOR ON STOCK, IT WAS OBSERVED THAT THERE WAS NO LOSS OF RESISTANCE ON THE LOR WHEN REACHING THE 10 ML. THIS CAUSED DELAY IN TREATMENT AND INCREASE COST DUE TO REPLACEMENT." ASSOCIATED COMPLAINTS 3006425876-2025-00180, 3006425876-2025-00181 AND 3006425876-2025-00179.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504783 ↗
• InjurySep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "INCIDENT OCCURRED ON (B)(6 ) 2024. IN THE DELIVERY ROOM, PATIENT: FEMALE 35-YEAR-OLD. INITIALLY INSERTION WITHOUT DIFFICULTY: LOSS OF RESISTANCE AT L2-L3 7 CM FROM THE SKIN. CATHETER INSERTED INTO THE EPIDURAL SPACE WITHOUT DIFFICULTY. WHEN THE CATHETER WAS MOVED IN ORDER TO ATTACH TO THE SKIN, A SUDDEN AND SPONTANEOUS CUT/BREAK OF THE PLASTIC SURROUNDING THE METAL FRAME OF THE CATHETER OCCURRED. THERE WAS A 13 CM SECTION OF PLASTIC LEFT IN THE PATIENT'S EPIDURAL SPACE. PATIENT HAS HAD AN MRI TO CONFIRM, THE SECTION OF CATHETER REMAINS IN THE PATIENT. ACCORDING TO NEURO-SURGEON 'NO SENSORIMOTOR DEFICIT, NO ABSOLUTE URGENCY TO REMOVE THE PORTION OF THE EPIDURAL CATHETER. A CT SCAN OR MRI TO BE PERFORMED AND AWAITING NEUROSURGICAL OPINION."

  Patient problems: Foreign Body In Patient

  MAUDE report 20244645 ↗
• MalfunctionAug 22, 2024Difficult to Advance; Difficult to Advance

  THERE WAS A PROBLEM ADVANCING THE CATHETER IN THE EPIDURAL SPACE. DEVICE WAS CHANGED. SENSATION OF RESISTANCE AGAIN, THEN SUDDENLY THE CATHETER ADVANCED, CREATING A BREACH / PUNCTURE IN THE DURA MATER. CONSEQUENCE: NEW EPIDURAL CATHETER INSERTED AND BLOOD PATCH APPLIED ON 47 HOURS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20040940 ↗
• MalfunctionApr 14, 2024Difficult to Remove; Stretched; Device Dislodged or Dislocated; Difficult to Remove; Stretched; Device Dislodged or Dislocated

  IT WAS REPORTED "THE NURSE WAS UNABLE TO REMOVE THE CATHETER. THE NURSE CALLED THE ANESTHETIST. THE ANESTHETIST OBSERVED THE DIFFICULTY ENCOUNTERED ON THE LAST FEW CENTIMETERS, WHICH HE EVALUATED AS DIFFICULT SINCE THE DEVICE IS FLEXIBLE." ADDITIONAL INFORMATION REPORTED "THE TIP OF THE CATHETER WAS SEVERELY STRETCHED OVER THE LAST THREE TO FOUR CENTIMETRES. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPROTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103105 ↗
• MalfunctionApr 10, 2024Material Separation; Material Separation

  IT WAS REPORTED "DURING REMOVAL FROM THE PATIENT, THE CATHETER BROKE. THE REMAINING CATHETER COULD BE COMPLETELY REMOVED. THE PATIENT WAS NOT HARMED." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077985 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED " THE EPIDURAL CATHETER WAS FOUND WITH A LEAK OF FLUID AT THE LEVEL OF THE PUNCTURE SITE.THE EPIDURAL THREAD WAS REMOVED AND IT WAS FOUND THAT THE FLUID WAS LEAKING FROM THE TIP OF THE CATHETER (WHICH IS NORMAL) BUT ALSO LEAKING ABOUT 10CM FROM THE TIP, WHICH IS NOT NORMAL." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITON IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013791 ↗
• MalfunctionFeb 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "LEAK AT LEVEL OF THE CATHETER TUBING WHEN TESTING THE DEVICE ONCE INSERTED". ADDITIONAL INFORMATION RECEIVED STATES "THERE WAS NO CONSEQUENCE FOR THE PATIENT". NO MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810972 ↗
• InjuryFeb 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT "DURING THE REMOVAL OF THE CATHETER, THE CATHETER BODY BROKE, AND A PIECE WAS LEFT IN THE FEMALE PATIENT. CLINICAL CONSEQUENCES: BACK PAIN AND THEN MORE IMPORTANT PAIN IN THE RIGHT LEG. NO MOTOR DYSFUNCTION OR SENSITIVE DEFICIT. IMAGING DONE". ADDITIONAL INFORMATION STATES, "A CT SCAN WAS PERFORMED. REPORT: PRESENCE OF MATERIAL IN POSTERIOR EPIDURAL AND POSTEROLATERAL LEFT L2-L3. ON 01 FEB, THE PATIENT WAS TRANSFERRED TO THE MATERNITY UNIT FOR POST- PARTUM CARE ON DAY 1 FOR REMOVAL OF AN EPIDURAL ANALGESIA CATHETER BROKEN IN THE EPIDURAL SPACE. AS THE CLINICAL EXAMINATION WAS REASSURING, THE REMOVAL OF THE CATHETER UNDER GA WAS NON-URGENT SURGERY AND GA WAS CONTRAINDICATED DURING THE FIRST 5 DAYS POSTPARTUM. PATIENT WAS ADVISED TO RESCHEDULE AN APPOINTMENT FROM DAY 6 POSTPARTUM, IF SHE SO WISHED. THE PATIENT'S CONDITION AT DISCHARGE WAS NORMAL".

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 18810822 ↗
• MalfunctionNov 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DEVICE WAS NOT USED BECAUSE THE SYRINGE PLUNGER WAS LEAKING." ADDITIONAL INFORMATION STATES THAT THIS OCCURRED "PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15790155 ↗
• MalfunctionDec 29, 2021Premature Separation; Premature Separation

  THE PLUNGER OF THE LOR SYRINGE SLIDES OUT OF THE SYRINGE BARREL WITHOUT ANY FORCE BEING APPLIED. THIS ISSUE WAS ALREADY NOTED ON APPROXIMATELY 20 DEVICES IN A PERIOD FROM OCTOBER TO DECEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112908 ↗
• MalfunctionDec 29, 2021Premature Separation; Premature Separation

  THE PLUNGER OF THE LOR SYRINGE SLIDES OUT OF THE SYRINGE BARREL WITHOUT ANY FORCE BEING APPLIED. THIS ISSUE WAS ALREADY NOTED ON APPROXIMATELY 20 DEVICES IN A PERIOD FROM OCTOBER TO DECEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112893 ↗
• MalfunctionDec 21, 2021Material Fragmentation; Material Fragmentation

  THE OBSTETRICS DEPARTMENT HAD TO DEAL WITH AN INCIDENT WITH AN EPIDURAL CATHETER LAST NIGHT (B)(6) 2021. WHEN REMOVING THE CATHETER AFTER CHILDBIRTH, A PART OF IT, APPROXIMATELY 5 OR 6 CM REMAINED IN THE PATIENT'S BODY. DOCTOR IS WONDERING IF IT IS POSSIBLE TO KEEP THIS PART IN THE BODY OR IF A NEUROSURGERY INTERVENTION BE PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052869 ↗
• MalfunctionOct 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE PLUNGER OF THE SYRINGE USED TO SEARCH FOR THE EPIDURAL SPACE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569072 ↗
• MalfunctionOct 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE PLUNGER OF THE SYRINGE USED TO SEARCH FOR THE EPIDURAL SPACE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569058 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WE FACED A SALINE LEAK ISSUE WITH THE LOR SYRINGE. THE PLUNGER WAS LEAKING. THE DEVICE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407281 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WE STILL OBSERVED LEAKS AT THE LEVEL OF THE PLUNGER OF THE LOR SYRINGE. THE LEAKS OCCURRED OVER THE LEVEL OF 6 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353058 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WE STILL OBSERVED LEAKS AT THE LEVEL OF THE PLUNGER OF THE LOR SYRINGE. THE LEAKS OCCURRED OVER THE LEVEL OF 6 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353024 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WE STILL OBSERVED LEAKS AT THE LEVEL OF THE PLUNGER OF THE LOR SYRINGE. THE LEAKS OCCURRED OVER THE LEVEL OF 6 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353019 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WE STILL OBSERVED LEAKS AT THE LEVEL OF THE PLUNGER OF THE LOR SYRINGE. THE LEAKS OCCURRED OVER THE LEVEL OF 6 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353015 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  WE STILL OBSERVED LEAKS AT THE LEVEL OF THE PLUNGER OF THE LOR SYRINGE. THE LEAKS OCCURED OVER THE LEVEL OF 6 ML. IT HAPPENED WITH SEVERAL SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103658. One submission often covers many models, so check the product and lot details in each record.

• Z-2364-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
• Z-1179-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
• Z-1962-2018 · Apr 11, 2018 · Terminated
  SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound