Ion 380707Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886874116241), received between Apr 4, 2022 and Feb 17, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PNEUMOTHORAX AFTER AN ION BIOPSY PROCEDURE. THE PATIENT REQUIRED CHEST TUBE PLACEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ION SYSTEM DID NOT EXHIBIT ANY ISSUES OR UNEXPECTED BEHAVIORS THAT MAY HAVE CONTRIBUTED TO THE PNEUMOTHORAX. THE LESION BIOPSIED WAS 7MM FROM THE PLEURA, AND MEASURED 9MM. IT WAS LOCATED IN THE RIGHT LOWER LOBE. NO DIAGNOSIS HAS BEEN DETERMINED. THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND CHEST PAIN, AND AN 8FR PIGTAIL CHEST TUBE WAS PLACED. THE PATIENT WAS ALSO PLACED ON OXYGEN. THE PHYSICIAN STATES IT IS UNKNOWN WHAT CAUSED THE PNEUMOTHORAX, WHICH WAS MODERATE IN SIZE, AND INCREASED OVER TIME. IN ADDITION TO MEDICAL TREATMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAS A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND HISTORY OF TOBACCO USE. THE PATIENT REMAINS HOSPITALIZED, PENDING DISCHARGE.

  Patient problems: Pneumothorax

  MAUDE report 24364704 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT AND HOSPITALIZATION FOR AN UNSPECIFIED AMOUNT OF TIME. NO ADDITIONAL INFORMATION WAS AVAILABLE. MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information; Pneumothorax

  MAUDE report 17177852 ↗
• MalfunctionMay 27, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE SYSTEM EXPERIENCED A 32098 RECOVERABLE FAULT WHEN PERFORMING CATHETER TESTS. THE ESR NOTED THAT THE ARMS WERE YELLOW, BUT THEY WERE UNABLE TO RECOVER THE FAULT. PRIOR TO CALLING IN THE ESR REBOOTED THE SYSTEM. TSE WAS ON PHONE WHEN THE SYSTEM POWERED ON AND ESR REPORTED A NON-RECOVERABLE FAULT 41066. TSE COMPLETED ALL TROUBLESHOOTING STEPS WITH NO RESOLUTION. THE SITE ELECTED TO ABORT THE PROCEDURE TO ANOTHER ION AT THIS TIME. THE DIAGNOSTIC PROCEDURE WAS CONVERTED TO ANOTHER ION WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015850 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE. THE BIOPSIED LESION WAS 1.8CM X 0.9CM X 1.6CM, AND LOCATED IN THE LEFT LOWER LOBE. THE DISTANCE TO PLEURA - CLOSEST EDGE WAS 4MM FROM PLEURAL BORDER. THE PNEUMOTHORAX WAS IDENTIFIED AFTER THE PROCEDURE VIA X-RAY IN THE PACU. THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN WAS UNSURE IF A PNEUMOTHORAX COULD HAVE POSSIBLY OCCURRED WITH ANOTHER MODALITY. THE SIZE OF THE PNEUMOTHORAX WAS UNKNOWN, BUT PER THE PHYSICIAN, THE PNEUMOTHORAX INCREASED IN SIZE. THE PATIENT RECEIVED A CHEST TUBE THE NEXT DAY AFTER THE ION PROCEDURE TO RESOLVE THE PNEUMOTHORAX. THE CHEST TUBE HAS BEEN REMOVED AND THE PATIENT WAS DISCHARGED HOME. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

  Patient problems: Pneumothorax

  MAUDE report 15993725 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PER THE PHYSICIAN, THERE WAS NO MALFUNCTION OF ION PRODUCTS AND THE DEVICE DID NOT CAUSE THE PNEUMOTHORAX. THE PROCEDURE WAS COMPLETED. THE PHYSICIAN STATED THE PNEUMOTHORAX COULD HAVE OCCURRED WITH ANOTHER MODALITY. THE BIOPSIED LESION WAS 2 CM AND LOCATED IN THE LEFT UPPER LOBE TOUCHING THE PLEURA. THE PNEUMOTHORAX OCCURRED POST PROCEDURALLY AND THE PATIENT WAS ASYMPTOMATIC. THE PNEUMOTHORAX WAS IDENTIFIED VIA CHEST X-RAY AND WAS MODERATE IN SIZE. AN X-RAY IS AVAILABLE FOR ISI REVIEW, BUT HAS NOT YET BEEN RECEIVED. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX. NO ADDITIONAL TREATMENTS WERE PROVIDED. THE PATIENT WAS HOSPITALIZED FOR 2 DAYS AND THEN DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Pneumothorax

  MAUDE report 15113538 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE. THE PHYSICIAN DID NOT NECESSARILY BELIEVE THE ION SYSTEM CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX, BUT POSSIBLY THE BIOPSY NEEDLE, AS IT IS A PART OF THE PROCEDURE TO RETRIEVE LUNG TISSUE AND IF THE BIOPSY LOCATION IS CLOSE TO THE PLEURA THERE IS AN INHERENT PROCEDURAL RISK THAT THE BIOPSY COULD LEAD TO A PNEUMOTHORAX. PER THE PHYSICIAN, THE PNEUMOTHORAX WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY. IN THIS CASE, THE SIZE OF THE LESION BIOPSIED WAS 13-15 MM AND WAS TOUCHING THE PLEURA. THE LESION WAS LOCATED IN THE LEFT UPPER LOBE (LUL). THE PROCEDURE WAS COMPLETED AND SEVERAL HOURS LATER A STANDARD POSTOPERATIVE CHEST X-RAY DID NOT REVEAL ANY RELEVANT PATHOLOGIC FINDINGS. THE PATIENT WAS DISCHARGED HOME WITHOUT ISSUES. HOURS LATER, THE PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA, CREPITUS, AND SHORTNESS OF BREATH AND WENT TO THE EMERGENCY ROOM. THE PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. NO OTHER TREATMENT INTERVENTIONS WERE PROVIDED. THE PATIENT WAS ADMITTED FOR A TOTAL OF 7 DAYS. THE PATIENT WAS DISCHARGED HOME IN STABLE CON

  Patient problems: Pneumothorax

  MAUDE report 14794459 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, BLEEDING WAS OBSERVED. HOWEVER, ACCORDING TO THE INITIAL REPORTER, THE CASE WENT WELL. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THERE WAS NO ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14780479 ↗
• InjuryApr 16, 2022Adverse 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. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX AND THE PATIENT REQUIRED HOSPITALIZATION FOR AN UNSPECIFIED DURATION. THE CAUSE OF THE PNEUMOTHORAX AND THE PROCEDURE OUTCOME ARE UNKNOWN. INTUITIVE SURGICAL INC. (ISI) MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THERE WAS NO RESPONSE RECEIVED FROM THE PHYSICIAN.

  Patient problems: Pneumothorax

  MAUDE report 14131793 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS IDENTIFIED BY A CHEST X-RAY. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX. IT IS UNKNOWN IF THE PATIENT REQUIRED HOSPITAL ADMISSION DUE TO THE COMPLICATION. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE PHYSICIAN TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HA BEEN RECEIVED.

  Patient problems: Pneumothorax

  MAUDE report 14104754 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED A DELAYED PNEUMOTHORAX. THE PATIENT WAS INITIALLY DISCHARGED AFTER THE PROCEDURE WITH NO COMPLICATIONS. THE NEXT DAY, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN AND SHORTNESS OF BREATH. AN X-RAY WAS PERFORMED CONFIRMING A MODERATE SIZED PNEUMOTHORAX. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX AND THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. REPORTEDLY, THE PATIENT HAS BEEN DISCHARGED AND IS DOING WELL. PER THE PHYSICIAN, THE SIZE OF THE LESION THAT WAS BIOPSIED WAS 1.5 CM. THE LESION WAS IN THE RIGHT MIDDLE LOBE, 2 CM FROM THE PLEURA. THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES REPORTED. THE PHYSICIAN STATED THE PATIENT WAS HIGH RISK FOR A PNEUMOTHORAX DUE TO A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PHYSICIAN BELIEVES THAT THE ION PRODUCTS DID NOT CAUSE OR CONTRIBUTE TO THE PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 13995425 ↗