ViziShot 2 FLEX NA-U403SX-4019Recalls & reported problems
Gyrus ACMI, LLC · SINGLE USE ASPIRATION NEEDLE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ViziShot 2 FLEX needle from Gyrus ACMI has 348 adverse event reports on file, with no deaths and 58 injuries. Reports describe needles breaking, parts detaching, outer sheaths getting punctured, and in some cases a broken needle piece left inside the patient. 1 open recall names this device: it began in August 2025 and concerns deformed tips that may go undetected.
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
- 349
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 349 adverse event reports that list this exact device (DI 00821925043060), received between Apr 23, 2020 and Sep 2, 2026 — classified as 59 injuries, 289 malfunctions.
The most frequently reported specific device problem is “Break” (68 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 6, 2025Class IOpen, Classified
Potential for undetected, deformed a-traumatic tips.
Z-2484-2025 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break68
- Detachment of Device or Device Component65
- Mechanical Problem54
- Retraction Problem31
- Material Twisted/Bent22
- Physical Resistance/Sticking19
- Material Separation18
- Material Puncture/Hole11
Patient problems
- No Clinical Signs, Symptoms or Conditions309
- Foreign Body In Patient18
- No Consequences Or Impact To Patient10
- Insufficient Information7
- Hemorrhage/Blood Loss/Bleeding4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Chest Pain2
- Hypoxia2
Recent adverse event reports
The 25 most recent of 349 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Break; Detachment of Device or Device Component
Patient problems: Unspecified Tissue Injury
MAUDE report 50576061 ↗MalfunctionFeb 9, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291591 ↗MalfunctionFeb 4, 2026Material Puncture/Hole
IT WAS REPORTED THE VIZISHOT 2 FLEX NEEDLE PERFORATED THE OUTER SHEATH. IT IS UNKNOWN WHEN THE MALFUNCTION OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260754 ↗MalfunctionFeb 3, 2026Fitting Problem; Failure to Eject
IT WAS REPORTED, THE VIZISHOT SHEATH HAD DIFFICULTY BEING REMOVED FROM THE DISTAL TERMINAL. THE ISSUE WAS FOUND DURING AN EBUS BRONCHOSCOPY DIAGNOSTIC 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 24254588 ↗MalfunctionFeb 3, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248284 ↗MalfunctionJan 22, 2026Material Perforation
IT WAS REPORTED THE ASPIRATION NEEDLE OUTER SHEATH OF NEEDLE WAS PERFORATED. THE ISSUE WAS FOUND DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148937 ↗InjuryJan 12, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SINGLE USE ASPIRATION NEEDLE PENETRATED THROUGH THE GUIDE AND A PIECE OF THE NEEDLE REMAINED AT THE PUNCTURE SITE IN THE LUNG. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE BROKEN NEEDLE FRAGMENT WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS THEN COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24038783 ↗MalfunctionJan 7, 2026Difficult to Remove
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23993021 ↗MalfunctionJan 7, 2026Difficult to Remove
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23992954 ↗MalfunctionDec 19, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE ASPIRATION NEEDLE WOULD NOT ADVANCE WHEN ATTEMPTING TO COLLECT A SAMPLE FOR HISTOLOGY. THIS ISSUE WAS FOUND DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857622 ↗MalfunctionDec 19, 2025Material Frayed; Failure to Advance; Material Frayed; Failure to Advance
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23856122 ↗MalfunctionDec 19, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THE VIZISHOT NEEDLE WAS NOT ADVANCING WHEN ATTEMPTING TO COLLECT THE SAMPLE FOR HISTOLOGY, THE NEEDLE WAS STUCK IN THE SHEATH. THE ISSUE WAS FOUND DURING ENDOBRONCHIAL ULTRASOUND (EBUS) DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23852532 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THE VIZISHOT 2 FLEX HAD A PARTIAL FRACTURE OF THE HYPOTUBE. THIS MALFUNCTION OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23841776 ↗MalfunctionDec 15, 2025Break; Break
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810463 ↗MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810353 ↗MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE VIZISHOT NEEDLE POINT WAS BENT. THERE WAS NO PROCEDURE THAT WAS IDENTIFIED. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804396 ↗MalfunctionDec 11, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE VIZISHOT 2 FLEX HAD A BENT NEEDLE POINT WHEN IT WAS TAKEN OUT OF ITS PACKAGING. THIS MALFUNCTION OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM/INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780515 ↗MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE VIZISHOT 2 FLEX HAD A BENT NEEDLE POINT WHEN IT WAS REMOVED FROM ITS PACKAGING. THIS MALFUNCTION WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771323 ↗MalfunctionDec 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE ASPIRATION NEEDLE POINT WAS BENT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761016 ↗MalfunctionDec 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE ASPIRATION NEEDLE POINT WAS BENT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760589 ↗MalfunctionDec 4, 2025Mechanical Jam; Mechanical Jam
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719524 ↗MalfunctionNov 24, 2025Failure to Advance; Failure to Advance
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638813 ↗MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23623529 ↗MalfunctionNov 21, 2025Material Puncture/Hole; Material Puncture/Hole
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23615832 ↗MalfunctionNov 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 23598305 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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