ARROW IPN923940Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902207361), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K121403); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, WHEN "THE [OPERATOR] WENT TO REMOVE THE INNER GUIDEWIRE, THE BLUE END FELL OFF. THEY WERE ABLE TO GET THE WIRE OUT, BUT THE CATHETER UNRAVELED AND KINKED TOWARDS THE TIP. THEY REPLACED THE CATHETER WITH ANOTHER AND THE SAME THING HAPPENED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713574 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121403. 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-1253-2020 · Dec 20, 2019 · Terminated
  (1) Arrow STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-180
• Z-1239-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
• Z-1241-2020 · Dec 20, 2019 · Terminated
  Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
• Z-1958-2018 · Apr 11, 2018 · Terminated
  Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
• Z-0573-2015 · Nov 10, 2014 · Terminated
  Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia technique
• Z-0546-2014 · Oct 9, 2013 · Terminated
  Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for