ARROW IPN923943Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902207392), received between Mar 24, 2023 and Mar 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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.

• MalfunctionMar 24, 2023Unsealed Device Packaging; Unsealed Device Packaging

  REPORTED ISSUE: THE SEAL WAS NOT COMPLETE AND THE COVER CAME OFF THE TRAY. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615042 ↗

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-1241-2020 · Dec 20, 2019 · Terminated
  Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
• Z-1239-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
• 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-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