ARROW IPN045632Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 50801902074190), received between Jun 26, 2019 and Feb 9, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Lack of Effect

  IT WAS REPORTED THAT "CLINICIAN REPORTED THAT FOLLOWING SPINAL PLACEMENT, THE EXPECTED ANESTHETIC EFFECT WAS NOT ACHIEVED AFTER ADMINISTRATION OF BUPIVACAINE WHICH LED TO CONVERSION TO GENERAL ANESTHESIA. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Insufficient Information

  MAUDE report 24289533 ↗
• MalfunctionFeb 6, 2026Lack of Effect

  IT WAS REPORTED THAT "CLINICIAN REPORTED THAT FOLLOWING SPINAL PLACEMENT, THE EXPECTED ANESTHETIC EFFECT WAS NOT ACHIEVED AFTER ADMI NISTRATION OF BUPIVACAINE WHICH LEAD TO CONVERSION TO GENERAL ANESTHESIA. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Insufficient Information

  MAUDE report 24276589 ↗
• MalfunctionFeb 6, 2026Lack of Effect

  IT WAS REPORTED THAT "CLINICIAN REPORTED THAT FOLLOWING SPINAL PLACEMENT, THE EXPECTED ANESTHETIC EFFECT WAS NOT ACHIEVED AFTER ADMINISTRATION OF BUPIVACAINE WHICH LED TO CONVERSION TO GENERAL ANESTHESIA. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Insufficient Information

  MAUDE report 24276580 ↗
• MalfunctionFeb 6, 2026Lack of Effect

  IT WAS REPORTED THAT "CLINICIAN REPORTED THAT FOLLOWING SPINAL PLACEMENT, THE EXPECTED ANESTHETIC EFFECT WAS NOT ACHIEVED AFTER ADMINISTRATION OF BUPIVACAINE WHICH LEAD TO CONVERSION TO GENERAL ANESTHESIA. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Insufficient Information

  MAUDE report 24276566 ↗
• MalfunctionOct 7, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01024, 9680794-2024-01023, 9680794-2024-01022, AND 9680794-2024-01021, 968 0794-2024-01012.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20381994 ↗
• MalfunctionOct 7, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01023, 9680794-2024-01022, AND 9680794-2024-01021, 968 0794-2024-01012.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20381981 ↗
• MalfunctionOct 7, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01024, 9680794-2024-01022, AND 9680794-2024-01021, 968 0794-2024-01012.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20381773 ↗
• MalfunctionOct 7, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01024, 9680794-2024-01023, AND 9680794-2024-01021, 968 0794-2024-01012.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20381716 ↗
• MalfunctionOct 7, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01024, 9680794-2024-01023, 9680794-2024-01022.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 20381709 ↗
• MalfunctionOct 7, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT: "BUPIVACAINE INCLUDED WITH SPINAL TRAY WAS INEFFECTIVE. 6 PATIENTS HAD TO BE TRANSITIONED TO GENERAL ANESTHESIA DUE TO PATIENTS MOVING AND RESPONDING DURING PROCEDURE. PT'S WERE UNDERGOING TOTAL HIP/TOTAL KNEE REPLACEMENTS." ASSOCIATED COMPLAINTS: 9680794-2024-01025, 9680794-2024-01024, 9680794-2024-01023, 9680794-2024-01022, AND 9680794-2024-01021.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20381690 ↗
• InjuryJun 5, 2024Material Separation; Material Separation

  IT WAS REPORTED "WHEN SPINAL NEEDLE REMOVED (C-SECTION PREP), APPROXIMATELY 4-5 CM OF NEEDLE MISSING, BROKEN OFF IN PATIENT. REQUIRED NEW SPINAL. REMOVAL DONE OF THE RFB (NEEDLE) AFTER DELIVERY OF THE BABY. SEPARATE PROCEDURE."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467699 ↗
• MalfunctionApr 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT "INTRODUCER NEEDLE BENT WITH VERY LITTLE MANIPULATION WHILE IN THE PATIENT. ANESTHESIA RETRACTED THE NEEDLE, BENT IT BACK TO STRAIGHTEN, AND IT SNAPPED". ADDITIONAL INFORMATION STATES THAT "NO HARM OCCURRED. THIS NEEDLE BENT IN THE PATIENT BUT BROKE EXTERNAL TO THE PATIENT". THE ISSUE WAS RESOLVED BY OPENING A NEW KIT AND USING A NEW INTRODUCER AND SPINAL NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769037 ↗
• MalfunctionDec 20, 2022Product Quality Problem; Product Quality Problem

  REPORTED ISSUE: WE RECEIVED NOTIFICATION FROM OUR ANESTHESIOLOGISTS THAT THE PATIENTS ARE NOT SETTING UP; THERE IS BAD BUPIVACAINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014717 ↗
• MalfunctionJun 26, 2019Break; Material Twisted/Bent

  INTRODUCER NEEDLES IN ARROW SPINAL TRAY BEND AND SNAP OFF AT HUB. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739513 ↗

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);