Flexision 490103Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00886874115961), received between Jun 16, 2022 and Sep 16, 2025 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, 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 ↗
• MalfunctionOct 3, 2024Positioning Problem; Positioning Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356816 ↗
• 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 ↗
• 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 1, 2023Defective Device

  REPORTED AS NEEDLE ASPIRATE BIOPSY WOULD NOT EXTEND FULLY FROM THE SHEATH AND WERE UNABLE TO BE USED TO RETRIEVE BIOPSIES.

  Patient problems: Insufficient Information

  MAUDE report 16843283 ↗
• MalfunctionApr 4, 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 EXTENDED AND BROKE INSIDE THE SHEATH. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679146 ↗
• MalfunctionMar 30, 2023Unintended Movement; Unintended Movement

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Chest Pain; Pneumothorax

  MAUDE report 16650168 ↗
• MalfunctionMar 24, 2023Retraction Problem

  ROBOTIC ION FLEXISION BIOPSY NEEDLE 21G FOR BRONCHOSCOPY NEEDLE USED X5 IN GOOD WORKING CONDITION. THE NEEDLE FAILED TO RETRACT INTO THE SHEATH ON THE 6TH PASS DURING THE PROCEDURE. THE DEVICE WAS WITHDRAWN FROM PATIENT. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16609214 ↗
• MalfunctionMar 21, 2023Failure to Advance; Separation Failure

  DURING BRONCHOSCOPY, TWO 21G FLEXISION BIOPSY NEEDLES WERE USED. BOTH NEEDLES WOULD NOT SEPARATE FROM THE CATHETER WELL WHILE TRYING TO OBTAIN BIOPSIES, AND THEY COULD NOT BE FULLY ADVANCED INTO THE TARGET STATION. DEVICE 1: (B)(4), 240630, L220017, EXP: 6/30/2024. DEVICE 2: (B)(4), 240731, L220024, EXP: 7/31/2024.

  Patient problems: Insufficient Information

  MAUDE report 16582000 ↗
• MalfunctionFeb 1, 2023Activation, Positioning or Separation Problem

  EIGHT DEVICES: ION 21G TBNA NEEDLE FAILED TO DEPLOY DURING THE BRONCHOSCOPY CASE. THE NEEDLE USED DURING ROBOTIC BRONCHOSCOPY WOULD NOT DEPLOY FROM THE SHEATH. THE SECOND NEEDLE WAS OPENED AND USED. ION 21G BIOPSY NEEDLE DEPLOYED THRU THE SIDE OF THE SHEATH. REP PULLED PRODUCTS FROM THE SHELF FOR RETURN TO THE MANUFACTURER. TWO SEPARATE LOT NUMBERS: L220015 (3 DEVICES) AND L220017 (5 DEVICES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276977 ↗
• InjuryDec 5, 2022Detachment 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 FAILED TO ADVANCE. 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921350 ↗
• MalfunctionNov 8, 2022Failure to Obtain Sample

  ACCORDING TO THE REPORT, THE FLEXISION BIOPSY NEEDLE, 21G DID NOT WORK PROPERLY DURING A BRONCHOSCOPY PROCEDURE. THE NEEDLE HAD TO BE REMOVED FROM THE SCOPE AND A NEW ONE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751480 ↗
• MalfunctionOct 7, 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 15567677 ↗
• InjuryJun 16, 2022Defective Device; Unintended Movement; Defective Device; Unintended Movement

  IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, AN ION SHEATH MOVED WHILE IN USE. WHEN THE PHYSICIAN DEPLOYED THE SHEATH, THE NEEDLE DID NOT COME OUT WHEN IT WAS PUSHED DOWN. UPON REMOVING THE CATHETER, THE NEEDLE WAS NOTED TO HAVE COME TO THE SIDE OF THE SHEATH. THE ISSUE DID NOT EFFECT THE PATIENT. NO INJURY WAS REPORTED DUE TO THIS ISSUE AND NO ADDITIONAL DEVICE FAILURE OCCURRED. DUE TO THE DEGREE OF DIFFICULTY OF THE BIOPSY, THE PHYSICIAN STATED HE USED MULTIPLE NON-ION INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PROBLEMS. THE PATIENT SEEMED FINE, BUT ON A ROUTINE CHEST X-RAY PERFORMED AN HOUR POST-PROCEDURALLY, A PNEUMOTHORAX WAS IDENTIFIED. AS A RESULT, A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX. THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN REPORTED THAT THE PATIENT REMAINED IN THE HOSPITAL FROM 48 TO 72 HOURS AND WAS DISCHARGED HOME IN STABLE CONDITION AND FULLY RECOVERED FROM THE PNEUMOTHORAX. THE PHYSICIAN EXPLAINED THAT THE PNEUMOTHORAX OCCURRED DUE TO THE SIZE AND POSITION OF THE LESION WHICH WAS VERY CLOSE TO THE PLEURA. THE PHYSICIAN FURTHER MENTIONED THAT THE PNEUMOTHORAX WOULD HAVE LIKELY OCCURRED VIA ANOTHER LUNG BIOPSY

  Patient problems: Pneumothorax

  MAUDE report 14721680 ↗