ARROW IPN045627Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 40801902074179), received between Aug 31, 2023 and Sep 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K911260); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT "ANESTHESIA PROVIDER PLACED THE SPINAL AND NOTED THE PLACEMENT WAS 'TEXTBOOK' AND WHEN THE BUPIVACAINE WAS INFUSED IT HAD NO AFFECT TO ANESTHETIZE THE PATIENT. THE PROVIDER THEN HAD TO UTILIZE AND EPIDURAL TO COMPLETE THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673542 ↗
• MalfunctionAug 31, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT "ANESTHESIA PROVIDER PLACED THE SPINAL AND NOTED THE PLACEMENT WAS 'TEXTBOOK' AND WHEN THE BUPIVACAINE WAS INFUSED IT HAD NO AFFECT TO ANESTHETIZE THE PATIENT. THE PROVIDER THEN HAD TO UTILIZE AND EPIDURAL TO COMPLETE THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665561 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K911260. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINA
• Z-1250-2020 · Dec 20, 2019 · Terminated
  Arrow SPINAL ANESTHESIA SET ASA-25090-S
• Z-2130-2020 · Oct 11, 2019 · Open, Classified
  Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavi
• Z-2129-2020 · Oct 11, 2019 · Open, Classified
  Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavi
• Z-0234-2020 · Aug 30, 2019 · Open, Classified
  SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box);