ARROW IPN040152Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902003447), received between Mar 29, 2024 and Mar 6, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "WE ARE USING A FLEX TIP PLUS EPIDURAL CATHETER 'EC-05500. IT BROKE AS THE NURSE AS REMOVING FROM THE PATIENT'S BACK. THE CATH BROKE EXTERNALLY (THE PART OF THE CATH THAT WAS TAPED TO THE PATIENT'S BACK). THE REMAINDER OF THE CATH WAS REMOVED WITHOUT DIFFICULTY AND THE CATH TIP WAS INTACT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535008 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "ANESTHESIA INSERTED AN EPIDURAL CATHETER INTO A PATIENT. THE CATHETER WENT IN SMOOTHLY AND IT WAS SECURED WITH A LOCKIT DEVICE. THE ANESTHESIOLOGIST THEN PROCEEDED TO DRAW BACK ON THE CATHETER WITH A MEDICATION SYRINGE AND AIR CAME INTO THE SYRINGE. THEY REALIZED SOMETHING WASN'T RIGHT WITH THE CATHETER AND SO THEY NOTICED THERE WAS A SEPARATION IN THE CATHETER. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300711 ↗
• InjuryMay 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "AT THE END OF THE SURGICAL PROCEDURE AN EPIDURAL CATHETER WAS PUT IN PLACE (PARAVERTEBRAL BLOCK) FOR PAIN CONTROL BY DR. AFTER THE SURGICAL INCISION WAS CLOSED IT WAS DETERMINED THAT THE PARAVERTEBRAL BLOCK WAS NOT WORKING, AND THE EPIDURAL CATHETER WAS REMOVED. IN DOING SO IT WAS NOTED BY DR. THAT A PORTION OF THE CATHETER TIP WAS MISSING AND STILL INSIDE THE PATIENT. A CHEST XRAY WAS ORDERED. THE THORACOTOMY CLOSURE WAS REOPENED AND THE CHEST CAVITY WAS SEARCHED. THE MISSING CATHETER PORTION WAS LOCATED AND AN INTRA OPERATIVE CHEST XRAY WAS PERFORMED TO DETERMINE THE CATHETERS COMPLETION. DR. AGREED THAT THE EPIDURAL CATHETER WAS COMPLETELY REMOVED FROM THE PATIENT THE PATIENT'S RIGHT THORACOTOMY INCISION WAS RECLOSED AND OR COUNTS WERE PERFORMED AS PER NURSING STANDARDS ".

  Patient problems: Foreign Body In Patient

  MAUDE report 19285729 ↗
• MalfunctionMar 29, 2024Device Markings/Labelling Problem; Migration; Device Markings/Labelling Problem; Migration

  IT WAS REPORTED "THE EPIDURAL CATHETER BECAME DISLODGED FROM THE PATIENT'S BACK WHEN HE WAS AMBULATING." ADDITIONAL INFORMATION REPORTED THE PATIENT UNDERWENT IMAGING AND WAS "DISCHARGED HOME WITH SEEMINGLY NO ADVERSE EVENTS". IT WAS DETERMINED THERE WAS NO REMAINING PIECES OF THE CATHETER INSIDE THE PATIENT. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004647 ↗

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