FlexisionRecalls & reported problems across all models

We found 3 models of Flexision by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Jul 22, 2021 and Sep 16, 2025 — classified as 8 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Flexision problems

Flexision models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Flexision 490103

  Bronchoscope (flexible or rigid)
  19 reports
• Flexision 490102

  Bronchoscope (flexible or rigid)
  8 reports
• Flexision 490104

  Bronchoscope (flexible or rigid)
  3 reports

Recent Flexision adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT THE THUMBSCREW ON THE BIOPSY NEEDLE WOULD NOT LOOSEN OR WORK DURING PROCEDURE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE THUMBSCREW WAS NOT WORKING AND COULD NOT BE CONTROLLED BY THE NURSE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065499 ↗
• MalfunctionMay 20, 2025Unintended System Motion; Material Twisted/Bent; Unintended System Motion; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A BIOPSY NEEDLE HAD A FRICTION ISSUE. THE PROCEDURE WAS COMPLETED. NO REPORTED KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057592 ↗
• MalfunctionMay 12, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT THE BIOPSY NEEDLE INSTRUMENT WAS NOTED TO HAVE FRICTION ISSUE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007205 ↗
• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE PHYSICIAN DID NOT HAVE ACCESS TO A LINEAR ENDO-BRONCHIAL ULTRASOUND (EBUS) SCOPE, SO USED THE ION FOR A MEDIASTINAL STAGING OF A 4R NODE (RIGHT LOWER PARATRACHEAL LYMPH NODE). AFTER THE BIOPSY, IT WAS SEEN WITH THE CAMERA THAT PART OF THE NEEDLE BROKE OFF AND WAS LODGED INTO THE ENDOTRACHEAL (ET) TUBE. AFTER EXTUBATING, THE PART OF THE NEEDLE WAS STILL IN THE TUBE. THERE WAS NO DELAY. THE PHYSICIAN WAS WELL AWARE THAT ION WAS NOT FOR STAGING. THE DIAGNOSTIC PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE MANAGER OF CLINICAL APPLICATIONS ENGINEERING: THE MEDICAL PERSONNEL STATED THAT THEY THREW THE ET TUBE WITH THE FRAGMENT AWAY AND DID AN AIRWAY SURVEY AFTER AND DID NOT SEE ANY OTHER FRAGMENTS IN THE AIRWAY. THE PATIENT WAS DOING WELL IN RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20447154 ↗
• MalfunctionOct 3, 2024Positioning Problem; Positioning Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356816 ↗
• MalfunctionSep 7, 2024Material Integrity Problem; Material Integrity Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20164709 ↗
• InjuryMay 14, 2024Patient Device Interaction Problem; Physical Resistance/Sticking; Patient Device Interaction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE DRAGGED AND WAS DIFFICULT TO DRAW BACK INTO THE SHEATH AFTER THE 3RD PASS; IT HAD LIMITED PASSES BEFORE IT BECAME UNUSABLE. IT WAS A ROUTINE PROCEDURE, BUT-POST PROCEDURE THE PATIENT EXPERIENCED A STROKE WITH MANIFESTATIONS OF LEFT-SIDED WEAKNESS AND DECREASED RESPONSIVENESS. THE PHYSICIAN REPORTED THERE WAS NO WAY TO KNOW IF A STROKE WOULD HAVE OCCURRED WITH ANOTHER DIAGNOSTIC MODALITY SINCE THERE WAS NO OTHER MODALITY APPROPRIATE FOR DIAGNOSIS AND THAT THE STROKE WAS LIKELY CAUSED BY PREEXISTING VASCULAR DISEASE AND TRANSIENT HYPOTENSION. THE PROCEDURE WAS NOT OVERLY LONG AT ROUGHLY ONE HOUR FOR BILATERAL BIOPSIES, AND THERE WAS MINIMAL ASSOCIATED BLEEDING. THE PATIENT REMAINS ILL AND HOSPITALIZED RELATING TO THE STROKE AND ITS COMPLICATIONS. THE PHYSICIAN DID NOT THINK THE STROKE WAS SPECIFICALLY RELATED TO THE ION PROCEDURE. PER THE PHYSICIAN, THERE WAS NO DEVICE MALFUNCTION; ONLY THE ONE BIOPSY NEEDLE)THAT HAD LIMITED PASSES BEFORE IT BECAME UNUSABLE.

  Patient problems: Stroke/CVA

  MAUDE report 19316273 ↗
• MalfunctionApr 12, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE WOULD NOT RETRACT INTO THE SHEATH DURING A BIOPSY. THE NEEDLE WAS SAFETY REMOVED FROM THE PATIENT WITH NOTHING LEFT BEHIND. THE CUSTOMER EMPTIED THE NEEDLE AT THE BEDSIDE AND FLUID CAME OUT OF THE TIP OF THE SHEATH RATHER THAN THE NEEDLE. THERE WAS ALSO A SMALL METAL FRAGMENT THAT IS BEING RETURNED IN SPECIMEN CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094421 ↗
• MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE NEEDLE BIOPSY BROKE. ALL PIECES ARE THERE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18128343 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX. THE PATIENT HAD DYSPNEA. THE PHYSICIAN THOUGHT THAT THE PNEUMOTHORAX MIGHT HAVE OCCURRED DURING THE PROCEDURE BUT WAS NOT DISCOVERED UNTIL AFTER THE PROCEDURE. THE PNEUMOTHORAX SIZE WAS LARGE, AND IT DID NOT GROW BIGGER. A CHEST TUBE WAS INSERTED, AND THE PATIENT WAS PLACED UNDER OBSERVATION. THE TARGET LESION WAS IN THE RIGHT LOWER LOBE, SUPERIOR SEGMENT, ATTACHED TO THE PLEURA AND ABOUT 1.7 CENTIMETERS IN SIZE. THE CAUSE OF THE PNEUMOTHORAX WAS ATTRIBUTED TO THE NATURE OF THE LESION AND THE USE OF FORCEPS INSTRUMENT FOR BIOPSY. A 21 G FLEXISION BIOPSY NEEDLE WAS USED AND THE SHEATH CAME OUT WITH THE NEEDLE. THE PHYSICIAN BELIEVE THAT THE PNEUMOTHORAX WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY. THE PATIENT IS CURRENTLY DISCHARGED HOME.

  Patient problems: Pneumothorax

  MAUDE report 17848803 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE WAS INSERTED INTO THE CATHETER AND DID NOT DEPLOY AT ALL. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596408 ↗
• MalfunctionJul 14, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE WOULD NOT EXTEND OUT OF THE SHEATH/RETRACT AFTER TWO PASSES. THE BIOPSY NEEDLE WAS STUCK IN THE SHEATH. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322824 ↗
• MalfunctionMay 26, 2023Product Quality Problem; Defective Component; Protective Measures Problem

  FLEXISION BIOPSY NEEDLE 21G, DURING BRONCHOSCOPY, HAD A FAILED SHEATH AND NEEDLE ON 3 SEPARATE NEEDLES. NEEDLES: #240930; LNN22002; EXP 09/30/2024; #240930; LNN22003; EXP 09/30/2024 AND #241031; LNN 22003; EXP 10/31/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009862 ↗
• MalfunctionMay 26, 2023Failure to Obtain Sample

  ION BIOPSY NEEDLE FOR BRONCHOSCOPY WOULD NOT EXTEND THE NEEDLE PAST THE SHEATH TO BE USED TO OBTAIN BIOPSIES.

  Patient problems: Insufficient Information

  MAUDE report 17009828 ↗
• MalfunctionMay 26, 2023Unintended Movement

  NEEDLE SHEATH THROUGH SIDE WALL, SHEATH MOVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 17009780 ↗

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