Ion 490105Recalls & reported problems
Intuitive Surgical, Inc. · Catheter · Class 2
Quick summary
This Intuitive Ion catheter is used with a bronchoscopy system to reach lung tissue. Reports mostly describe catheter parts detaching or failing pre-use checks, with tip control problems during lung biopsy and sometimes fragments left in the patient or bleeding mentioned. There are 26 reports naming its identifier, with no deaths and 5 injuries. It has 1 closed recall from October 2020 because the distal tip ring could become dislodged during a procedure.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00886874116258), received between Sep 30, 2020 and Jun 6, 2025 — classified as 5 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Oct 23, 2020Terminated
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Z-0489-2021 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component9
- Failure of Device to Self-Test3
- Defective Component2
- Activation Failure1
- Crack1
- Defective Device1
- Device Dislodged or Dislocated1
- Failure to Calibrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information7
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Positioning Problem; Positioning Problem
IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE CATHETER WOULD NOT RELAX AND THE PATIENT EXPERIENCED HEMORRHAGING. THE PHYSICIAN WAS AT THE END OF THE ION PROCEDURE AND WHILE TRYING TO RETRACT THE CATHETER IT WOULD NOT RELAX. A FLUOROSCOPY WAS PERFORMED, AND IT WAS NOTED THAT THE CATHETER WAS HOOKED. THE PHYSICIAN WAS INSTRUCTED TO PULL BACK ON THE CONTROLLER AND WHEN THE CATHETER WAS RETRACTED HEMORRHAGING WAS OBSERVED FROM THE BIOPSIED LOBE. THE PHYSICIAN BELIEVED THE CAUSE OF BLEEDING WAS DUE TO THE CATHETER ISSUE. THE PHYSICIAN ADMINISTERED UNSPECIFIED MEDICATION VIA AN ENDOSCOPE TO CONTROL THE BLEEDING. THERE WAS A DELAY OF ABOUT 30 MINUTES, BUT THE BLEEDING WAS SOLVED. AN X-RAY WAS PERFORMED AND PER THE PHYSICIAN, IT WAS A MODERATE AMOUNT OF BLEEDING IN THE BIOPSIED LOBE (UNSPECIFIED). THE PHYSICIAN DID NOT REMEMBER THE EXACT AMOUNT OF BLOOD LOSS, BUT STATED NO TRANSFUSION WAS REQUIRED. THE PHYSICIAN DID A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN TO DECIDE IF THE PATIENT WOULD NEED TO STAY IN THE HOSPITAL OVERNIGHT - THE PATIENT WAS OBSERVED AND DISCHARGED HOME. PER THE PHYSICIAN, THERE WERE NO OTHER ISSUES WITH THE ION SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22158623 ↗MalfunctionAug 9, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE FULLY ARTICULATING CATHETER TIP STARTED GOING IN CIRCLES IN THE UPPER LEFT LOBE. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF THE FULLY ARTICULATING CATHETER TIP WAS DRAWING CIRCLES, AND THE CUSTOMER CONFIRMED. THE CUSTOMER HAD NAVIGATED TO THE FIRST TARGET IN THE RIGHT UPPER LOBE WITH NO ISSUES. THE ISSUE ONLY HAPPENED WHEN THE CUSTOMER WAS NAVIGATING TO THE SECOND TARGET IN THE LEFT UPPER LOBE. PRIOR TO CONTACTING THE ISI TSE, THE CUSTOMER REPLACED THE FULLY ARTICULATING CATHETER AND PERFORMED REGISTRATION. THE TSE REVIEWED SYSTEM LOGS AND IDENTIFIED MULTIPLE BEND STRAIN ERRORS DURING PREVIOUS ATTEMPT TO TARGET. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FULLY ARTICULATING CATHETER WAS INSPECTED PRIOR TO USE, AND NOTHING WAS OBSERVED OUT OF THE ORDINARY. THERE WAS NO PATIENT INJURY. AN ISI ENDOLUMINAL SALES REPRESENTATIVE (ESR) PROVIDED ADDITIONAL INFORMATION: THIS ISSUE OCCURRED AFTER THE FIRST BIOPSY BUT PRIOR TO THE SECOND
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955666 ↗MalfunctionApr 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE FULLY ARTICULATING CATHETER WAS NOT ENGAGING AND WAS SHREDDING. THE CUSTOMER WAS NOT SURE IF IT WAS CAUSED BY THE BIOPSY NEEDLE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19149558 ↗MalfunctionNov 9, 2023
MalfunctionOct 19, 2023
HOLE IN CATHETER CLOSE TO CIRCUIT HOUSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17964454 ↗MalfunctionSep 12, 2023
THE CATHETER DID NOT PASS CONDUCTIVE TESTING PRIOR TO USE ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17728498 ↗MalfunctionSep 4, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17675154 ↗MalfunctionJun 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17196071 ↗MalfunctionJun 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, WHEN THE VISION PROBE WAS PUT THROUGH THE CATHETER GUIDE, THERE WAS A YELLOW RING AND THE CUSTOMER WAS UNABLE TO VISUALIZE TO MOVE FORWARD WITH THE PROCEDURE. THE CUSTOMER PERFORMED MULTIPLE ATTEMPTS TO TRY TO GET THE CATHETER GUIDE TO WORK UNTIL SWITCHING TO A NEW ONE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17122881 ↗MalfunctionMay 25, 2023Crack; Fluid/Blood Leak
THE CATHETER HAS A CRACK IN THE TIP WITH FLUID INVASION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001622 ↗MalfunctionMay 1, 2023Infusion or Flow Problem; Activation Failure
THE CATHETER DID NOT PASS CONTINUITY TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843302 ↗MalfunctionApr 18, 2023Failure of Device to Self-Test
MalfunctionApr 18, 2023Failure of Device to Self-Test
THE CATHETER DID NOT PASS PROCEDURAL PRE-CHECK.
Patient problems: Insufficient Information
MAUDE report 16760801 ↗MalfunctionMar 21, 2023Incorrect, Inadequate or Imprecise Result or Readings
ION CATHETER DID NOT PASS CONTINUITY TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16581930 ↗MalfunctionMar 6, 2023Failure to Calibrate
ION FULLY ARTICULATING CATHETER FAILED TO CALIBRATE BEFORE THE PROCEDURE, ATTEMPTED X4.
Patient problems: Insufficient Information
MAUDE report 16484926 ↗MalfunctionMar 6, 2023Defective Component
CATHETER DID NOT PASS THE CONTINUITY TEST.
Patient problems: Insufficient Information
MAUDE report 16484898 ↗MalfunctionFeb 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO THE START OF AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CATHETER INSTRUMENT DISTAL TIP HAD A METAL BLOCKING. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16440892 ↗MalfunctionFeb 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER NOTICED A PIECE DISLODGED INSIDE THE CATHETER, IT DID NOT GO INSIDE THE PATIENT. THE CUSTOMER TRIED TO REMOVE BUT IT WAS JUST STUCK INSIDE THE CATHETER. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16368449 ↗MalfunctionFeb 6, 2023Material Discolored; Defective Device; Scratched Material
TWO DEVICES: (B)(6) 2022 UPON REPROCESSING EQUIPMENT, IT WAS FOUND TO HAVE A SCRATCH OR TEAR NEAR THE DISTAL TIP OF ARTICULATING CATHETER, A DISCOLORATION WAS ALSO NOTED INTERNALLY AROUND THE AREA OF DEFECT. (S11220901 0013). (B)(6) 2022 POSSIBLE FLUID INVASION, EQUIPMENT DID NOT PASS PRE-CHECKS FOR PROCEDURE (S11220901 0016).
Patient problems: Insufficient Information
MAUDE report 16303105 ↗InjuryJan 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO THE START OF AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CATHETER WAS FOUND TO BE DEFECTIVE. THE DEVICE WAS NOT USED ON THE PATIENT AT THE TIME. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON, RECORDED IN THE SYSTEM AS HAVING PERFORMED THE (B)(6) 2022 PROCEDURE, AND INDICATED THAT, WHILE WATCHING THE PROCEDURE RECORDING, THE SURGEON SAW THE VISION PROBE (VP) GOING PAST THE CATHETER TIP WHEN USING FLUORESCENCE. THE SURGEON WAS NOT SURE WHY IT WAS NOT A CONCERN TO HIM AT THE TIME. THE SURGEON HAD NOT SEEN THE TIP RING IN THE RECORDING. THE SURGEON REPORTED THAT POST-PROCEDURE IMAGING (CT SCAN AND X-RAY) SHOWED NO VISIBLE RING. THE CATHETER TIP RING WAS RETAINED BY THE PATIENT WITHOUT RETRIEVAL. THE SURGEON WAS NOT ABLE TO REACH THE TARGET AND CAPTURE A SAMPLE DURING PROCEDURE. THE SURGEON SUSPECTED THAT THE LESION WAS BENIGN. THE SURGEON STATED THAT THE PATIENT PRESENTED IN GOOD HEALTH AT THE FOLLOW-UP CT IN (B)(6) 2022 AND HAD ANOTHER SUBSEQUENT FOLLOW-UP CT PLANNED ON AN UNSPECIFIED DATE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16118575 ↗MalfunctionDec 20, 2022Failure of Device to Self-Test
REPORTED THAT THE CATHETER WOULD NOT PASS THE SELF-TEST AFTER 6 TRIES.
Patient problems: Insufficient Information
MAUDE report 16014032 ↗MalfunctionSep 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481734 ↗InjurySep 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE SYSTEM HAD A RING DISPLAYED IN THE IMAGE. THE CUSTOMER REMOVED THE VISION PROBE, REINSERTED. AND THE ISSUE REMAINED SAME. AN ENDOLUMINAL SALES REPRESENTATIVE (ESR) RECOMMENDED THE CUSTOMER TO GET A BACKUP VISON PROBE AND WHILE THEY WERE WAITING FOR THE BACKUP, THE PHYSICIAN ELECTED TO CONTINUE AND NAVIGATE TO THE TARGET. WHILE THE CUSTOMER WAS NAVIGATING, THE ESR SUGGESTED THAT THE CATHETER COULD BE THE ISSUE. THE CUSTOMER NAVIGATED TO THE TARGET, SWITCHED TO A BACKUP VISION PROBE AND THE ISSUE REMAINED. THE CUSTOMER ELECTED TO CONTINUE AND INSTALLED THE FORCEPS. WHILE INSERTING THE FORCEPS, THE CUSTOMER NOTED A SCREW THAT HAD FALLEN OFF THE FORCEPS OR THE CATHETER AND FELL INTO THE PATIENT. THE CUSTOMER CONFIRMED THE PRESENCE OF THE SCREW UNDER FLUORO AND RETRIEVED THE SCREW. THE ESR STATED THAT WHILE INSERTING THE VISON PROBE, THE PROBE EXTENDED PAST THE TIP OF THE CATHETER. 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 ON 31-AUGUST-2022: ALL FRAGMENT(S) WERE RETRIEVED B
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15481732 ↗MalfunctionMay 28, 2022Defective Component; Defective Component
IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, A PLASTIC PIECE WAS STUCK IN A CATHETER. 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 NO FRAGMENT FALL INTO THE PATIENT. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14538662 ↗InjuryOct 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10671859 ↗
Other Bronchoscope (flexible or rigid) devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.