PeriView FLEX NA-403D-2021Recalls & reported problems
Gyrus ACMI, LLC · SINGLE USE ASPIRATION NEEDLE (4/PK) · Class 2
Quick summary
This Gyrus ACMI single-use aspiration needle is used during bronchoscopy procedures to take samples from inside the lung. Most of the 54 reports describe mechanical trouble with the needle: bent or twisted parts, pieces breaking off, sticking or resistance during retraction, and missing components. A few mention patient effects such as a punctured plastic sheath, a foreign body left in the patient, and one each of pneumothorax, hypoxia, and pneumonia. Four reports involve injuries and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00821925042513), received between Apr 27, 2021 and Aug 28, 2026 — classified as 4 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (14 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent14
- Break5
- Physical Resistance/Sticking5
- Retraction Problem5
- Component Missing4
- Mechanical Problem4
- Deformation Due to Compressive Stress3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Pneumothorax2
- Foreign Body In Patient1
- Hypoxia1
- Pneumonia1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Material Perforation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509735 ↗InjuryAug 25, 2026Break; Detachment of Device or Device Component
It was reported that during a robotic bronchoscopy procedure, the single-use aspiration needle separated from the sheath at the sheath-to-needle interface. As a result, a fragment of the needle became dislodged and remained within the patient. The needle fragment was briefly visualized via the bronchoscope; however, due to patient respiratory movement, it migrated from the visualized location and could not be identified again. The clinical team conducted a search and retrieval effort but was unable to locate or retrieve the retained needle fragment. The procedure was delayed by greater than 30 minutes, without any reports of patient harm. No additional information regarding the event has been provided at this time.
Patient problems: Foreign Body In Patient
MAUDE report 50441500 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309217 ↗MalfunctionJan 28, 2026Mechanical Jam
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203565 ↗MalfunctionJan 5, 2026Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23965832 ↗MalfunctionDec 22, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865931 ↗MalfunctionDec 1, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD A PLASTIC SHEATH THAT WAS PUNCTURED. THE ISSUE OCCURRED DURING A DIAGNOSTIC TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE. THERE WAS LESS THAN A THIRTY MINUTE DELAY AND THE PROCEDURE WAS COMPLETED WITH A COMPETITORS' DEVICE. THERE WAS NO HARM TO THE PATIENT ASSOCIATED WITH THIS EVENT. THE PLASTIC SHEATH OF THE NEEDLE WAS PUNCTURED. THERE WAS NO HARM TO THE PATIENT. PROCEDURE COMPLETED WITH FB-433D BIOPSY FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688513 ↗MalfunctionJul 15, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THE SUBJECT DEVICE HAD A STYLET THAT WAS BENT DURING A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22513704 ↗MalfunctionJul 14, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD AN INCOMPLETE RETRACTION ISSUE DURING A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22501033 ↗MalfunctionJun 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SUBJECT DEVICE NEEDLE WAS BENT AT THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203174 ↗MalfunctionApr 25, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21910477 ↗InjurySep 4, 2024Firing Problem; Firing Problem
IT WAS REPORTED THAT DURING TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, NO SAMPLE COULD BE OBTAINED WITH A BIOPSY OR CYTOLOGY BRUSH. CONSEQUENTLY, THE CUSTOMER OPTED TO USE THIS ASPIRATION NEEDLE; HOWEVER, THE NEEDLE DID NOT COME OUT AND THE TEST ENDED. ADDITIONALLY, AS THE PATIENT'S CONDITION "NOT BEING GOOD AND IT WAS TAKING TIME," THE PROCEDURE WAS DISCONTINUED. AS REPORTED, NO ADDITIONAL BIOPSIES WILL BE PERFORMED, AND A SCHEDULED OPERATION ON AUGUST 30TH WAS NOT PERFORMED, AS A RESULT. THERE WERE NO REPORTS OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140202 ↗MalfunctionAug 12, 2024Device Stenosis; Device Stenosis
IT WAS REPORTED, THE SUBJECT DEVICE WAS UNABLE TO ADVANCE THE NEEDLE IN THE GUIDE SHEATH, AS IF THE GUIDE SHEATH CHANNEL NARROWS. THE ISSUE WAS FOUND PRIOR TO THE DEVICE ENTERING THE SCOPE/PATIENT DURING A THERAPEUTIC RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. NO SURGICAL DELAY AND NO PATIENT HARM WAS REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19959980 ↗MalfunctionAug 9, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED, DURING A DIAGNOSTIC RADIAL PROBE PROCEDURE THE SUBJECT DEVICE A HAD PLASTIC SHEATH THAT WAS TIGHT ON THE NEEDLE AND WHEN PUSHING THE NEEDLE, THE PLASTIC SHEATH WAS EXTENDING. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19951429 ↗MalfunctionAug 9, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: THE ISSUE OCCURRED DURING A DIAGNOSTIC RADIAL PROBE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19951343 ↗MalfunctionAug 9, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED, DURING A DIAGNOSTIC RADIAL PROBE PROCEDURE THE SUBJECT DEVICE A HAD PLASTIC SHEATH THAT WAS TIGHT ON THE NEEDLE AND WHEN PUSHING THE NEEDLE, THE PLASTIC SHEATH WAS EXTENDING. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950816 ↗MalfunctionAug 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A THERAPEUTIC RADIAL EBUS PROCEDURE, THE ASPIRATION NEEDLE WAS UNABLE TO ADVANCE IN THE GUIDE SHEATH. IT SEEMS AS IF THE GUIDE SHEATH CHANNEL NARROWS, NOT ALLOWING THE DEVICE TO PASS. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19910506 ↗MalfunctionJul 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED FOR SINGLE USE ASPIRATION NEEDLE, NEEDLE WAS HAD A BENT SHEATH AND WAS DAMAGED WHEN PACKAGE WAS FIRST OPENED DURING A NAVIGATION BRONCHOSCOPY PROCEDURE. NEEDLE WAS NOT USED ON PATIENT AND THROWN AWAY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19746364 ↗MalfunctionJun 17, 2024Break; Break
IT WAS REPORTED THE NEEDLE WAS BROKEN WHEN THE PACKAGE WAS OPENED. THE EVENT WAS FOUND DURING PREPARATION FOR USE AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548804 ↗MalfunctionJun 14, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE DID NOT SLIDE WELL INSIDE THE GUIDE SHEATH. IT WAS VERY TIGHT, AND IT WAS HARD TO GET THE NEEDLE IN AND HARD TO GET IT OUT. WHEN THE RESPIRATION THERAPIST (RT) WANTED TO TAKE THE NEEDLE OUT IN ORDER TO COLLECT THE SAMPLE, IT DID NOT COME OUT BECAUSE THE GUIDE SHEATH ITSELF HAD STRETCHED DURING INTRODUCTION AND REMOVAL. THE ISSUE OCCURRED DURING A THERAPEUTIC RADIAL EBUS (ENDOBRONCHIAL ULTRASOUND) BRONCHOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19538746 ↗MalfunctionMay 22, 2024Ejection Problem; Ejection Problem
IT WAS REPORTED THAT DURING A RADIAL-EBUS THERAPEUTIC PROCEDURE, IT WAS DIFFICULT TO GET THE ASPIRATION NEEDLE IN AND STILL DIFFICULT TO GET IT OUT AND THE GUIDESHEATH OF THE NEEDLE HAD STRETCHED DURING INSERTION OR WITHDRAWAL. THE PROCEDURE WAS DELAYED AND COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19378770 ↗MalfunctionApr 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE ASPIRATION NEEDLE COULD NOT BE INSERTED TO THE END. THE MALFUNCTION OCCURRED DURING A DIAGNOSTIC PROCEDURE FOR ASPIRATION BIOPSY WHEN USED IN COMBINATION WITH THE GUIDED SHEATH. THE PHYSICIAN USED A DIFFERENT ASPIRATION NEEDLE WHICH COULD BE INSERTED; HOWEVER, THE NEEDLE DID NOT COME OUT OF THE TIP. THE PROCEDURE WAS COMPLETED USING BIOPSY FORCEPS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19187235 ↗MalfunctionApr 9, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE SHEATH GUIDE OF THE SINGLE USE ASPIRATION NEEDLE WAS DRAWN WHEN RETRACTING THE NEEDLE FROM THE KIT, AND IT WAS IMPOSSIBLE TO REMOVE THE NEEDLE. THE ISSUE WAS FOUND DURING A DIAGNOSTIC RADIAL ENDOBRONCHIAL ULTRASOUND. THE PROCEDURE WAS PROLONGED FOR AN UNSPECIFIED AMOUNT OF TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19071612 ↗MalfunctionApr 9, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE SHEATH GUIDE OF THE SINGLE USE ASPIRATION NEEDLE WAS DRAWN WHEN RETRACTING THE NEEDLE FROM THE KIT, AND IT WAS IMPOSSIBLE TO REMOVE THE NEEDLE. THE ISSUE WAS FOUND DURING A RADIAL ENDOBRONCHIAL ULTRASOUND. THE PROCEDURE WAS PROLONGED FOR AN UNSPECIFIED AMOUNT OF TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19071342 ↗MalfunctionMar 25, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE PUNCTURED THE SCOPE SHEATH AND WAS DAMAGED DURING AN UNIDENTIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18973444 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.