Ion 490305Recalls & reported problems
Intuitive Surgical, Inc. · Catheter · Class 2
All models of Ion (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Intuitive Surgical Ion articulating bronchoscope catheter is used during endobronchial procedures in the lung. Most reports describe the catheter not working at all — error codes, failed connection or continuity tests, and loss of image articulation — plus some describe it moving on its own or small pieces breaking off, in one case leaving a fragment in the patient. There are 27 reports, no deaths, and 2 injuries. No recalls name 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
- 29
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00886874124796), received between Jul 20, 2024 and Sep 28, 2026 — classified as 2 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement5
- Material Fragmentation4
- No Apparent Adverse Event3
- Failure to Conduct2
- Leak/Splash2
- Material Deformation2
- No Device Output2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information4
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Unintended Movement
Patient problems: Insufficient Information
MAUDE report 50923766 ↗MalfunctionSep 22, 2026Appropriate Device Problem Term/Code Not Available
It was reported that during an Ion Endoluminal Lung Biopsy, the fully articulating catheter reportedly exploded in the nursing assistant's hands during the pre-disinfection step. No patient involvement.Intuitive Surgical (IS) obtained the following additional information regarding this event: It was confirmed that the nurse did not suffer any injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851999 ↗MalfunctionJul 30, 2026Unintended System Motion
Refer to H11 for Follow-Up information.
Patient problems: Insufficient Information
MAUDE report 50093863 ↗MalfunctionMay 4, 2026No Device Output
IT WAS REPORTED THAT THE CATHETER WAS HAVING ERROR MESSAGE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074369 ↗MalfunctionMay 4, 2026No Device Output
IT WAS REPORTED THAT PRIOR TO THE START OF AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE FULLY ARTICULATING CATHETER WAS UNABLE TO CONNECT, HAD AN ERROR CODE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074254 ↗MalfunctionMay 1, 2026Unintended Movement
IT WAS REPORTED THAT THE FULLY ARTICULATING CATHETER HAD AN ALTERED IMAGE ARTICULATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056121 ↗MalfunctionApr 24, 2026Failure to Conduct
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FULLY ARTICULATING CATHETER WAS NOT FUNCTIONING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24990327 ↗MalfunctionApr 20, 2026Explosion
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927888 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FULLY ARTICULATING CATHETER HAD A MINI EXPLOSION LEADING TO PIECES WENT EVERYWHERE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849314 ↗MalfunctionApr 8, 2026
FAILED CONTINUITY TEST..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815032 ↗MalfunctionApr 2, 2026
RECEIVED ERROR MESSAGE "REMOVE CATHETER: REATTACH CATHETER AND ENSURE CLEARANCE AROUND TIP. ERROR 28010" ATTEMPTED REATTACHMENT SEVERAL TIMES WITH THE SAME ERROR MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765706 ↗MalfunctionFeb 12, 2026
ION ARTICULATING CATHETER FAILED LEAK TEST AFTER PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321783 ↗MalfunctionFeb 9, 2026Material Fragmentation
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299549 ↗MalfunctionJan 8, 2026Output Problem
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT A CATHETER TIP MOTION MESSAGE AND PATIENT MOTION DETECTED DURING A PROCEDURE. THE PHYSICIAN REMOVED ALL INSTRUMENTS AND ACCESSORIES, RE-SETUP, AND RE-NAVIGATED TO THE TARGET TO CONTINUE THE PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY. IT WAS NOTED THAT THE ONSITE SYSTEM WAS PLUGGED IN BUT NOT SHOWING AS CONNECTED. TECHNICAL SUPPORT RECOMMENDED PERFORMING A HARD POWER CYCLE AND USING A NEW ETHERNET CABLE TO UPLOAD THE LOGS. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE PHYSICIAN ALLEGED THAT THE CATHETER MOVED ON ITS OWN, WITHOUT ANY USER INPUT FROM THE TRACKBALL OR SCROLL WHEEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24015721 ↗MalfunctionDec 22, 2025Leak/Splash
ION CATHETER HEAD FAILED LEAK TEST AFTER PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862819 ↗MalfunctionDec 15, 2025Leak/Splash
ION ARTICULATING CATHETER HEAD FAILED LEAK TEST AFTER PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23801932 ↗MalfunctionNov 14, 2025Failure to Conduct; Failure to Conduct
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FULLY ARTICULATING CATHETER HAD LEAKAGE TO HIGH. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS UNKNOWN ABOUT THIS SPECIFIC CASE DUE TO NUMEROUS CATHETERS BEING SENT BACK. THERE WERE NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23561134 ↗MalfunctionOct 20, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT THE SURGEON EXPERIENCED A SIGNIFICANT AMOUNT OF CATHETER DRIFT. IT WAS STATED THAT DURING THE BREATH HOLD THE CATHETER WOULD DRIFT INFERIORLY. THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23340751 ↗MalfunctionSep 4, 2025Circuit Failure
CATHETER) FAILED CONTINUITY TEST AFTER SEVERAL ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962032 ↗MalfunctionJul 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING CENTRAL PROCESSING WHEN CONDUCTING THE CONTINUITY TEST, THE HEAD BROKE INTO SEVERAL PIECES. ACCORDING TO THE TECH IT BURST OPEN ON THE PROCESSOR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 22504033 ↗MalfunctionJul 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT PRIOR TO THE START OF AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE TIP OF THE CATHETER IS BENT. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22488104 ↗MalfunctionMay 2, 2025Unintended Movement; Unintended Movement
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21955384 ↗MalfunctionApr 28, 2025Material Fragmentation; Material Fragmentation
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21916446 ↗InjuryFeb 25, 2025Material Fragmentation; No Apparent Adverse Event; Material Fragmentation; No Apparent Adverse Event
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21464362 ↗InjuryFeb 25, 2025Material Fragmentation; No Apparent Adverse Event; Material Fragmentation; No Apparent Adverse Event
IT WAS REPORTED THAT A FRAGMENT FELL OFF THE FULLY ARTICULATING CATHETER, AND IT IS UNKNOWN IF IT WAS RETRIEVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21460622 ↗
Other Bronchoscope (flexible or rigid) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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