ARROW IPN045759Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902064070), received between Nov 16, 2023 and May 12, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT: "LAST WEEK WE HAD TWO DIFFERENT ANESTHESIA PROVIDERS HAVE ISSUES W/ SPINALS NOT WORKING AND THEY BELIEVE IT WAS THE DRUGS IN THE KIT.' I SPOKE WITH OUR CHIEF OF ANESTHESIA, AND HE CONFIRMED THAT THE BUPIVACAINE HAD NO EFFECT ON THE PATIENTS, AND THE KITS THEMSELVES WERE FINE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPROTED AS FINE PSOT THE PROCEDURE. ASSOCIATED COMPLAINTS: 9680794-2025-00402.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001000 ↗
• MalfunctionMay 12, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT: "LAST WEEK WE HAD TWO DIFFERENT ANESTHESIA PROVIDERS HAVE ISSUES W/ SPINALS NOT WORKING AND THEY BELIEVE IT WAS THE DRUGS IN THE KIT.' I SPOKE WITH OUR CHIEF OF ANESTHESIA, AND HE CONFIRMED THAT THE BUPIVACAINE HAD NO EFFECT ON THE PATIENTS, AND THE KITS THEMSELVES WERE FINE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPROTED AS FINE PSOT THE PROCEDURE. ASSOCIATED COMPLAINTS: 9680794-2025-00402 AND 9680794-2025-00403.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000628 ↗
• MalfunctionDec 4, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT "THE DRUG DIDN'T MAKE OR KEEP THE PATIENT NUMB". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". ASSOCIATED TO 9680794-2023-00926 AND 9680794-2023-00927.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254908 ↗
• MalfunctionDec 4, 2023Device Handling Problem; Patient Device Interaction Problem; Device Handling Problem; Patient Device Interaction Problem

  THERE WERE 3 INSTANCES WHERE THE DRUG DIDN'T MAKE OR KEEP THE PATIENT NUMB, IT HAPPENED WITH DIFFERENT PROVIDERS. ASSOCIATED TO 9680794-2023-00928 AND 9680794-2023-00926.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254253 ↗
• MalfunctionNov 16, 2023Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT "THE DRUG DIDN'T MAKE OR KEEP THE PATIENT NUMB". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151023 ↗

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);