Ion 380748Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,278 adverse event reports that list this exact device (DI 00886874116234), received between Jun 30, 2020 and Sep 30, 2026 — classified as 97 deaths, 1,170 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (20 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 12, 2024Open, Classified

   There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

   Z-2720-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,278 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumothorax

  MAUDE report 50955113 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an Ion procedure, followed by bronchoalveolar lavage (BAL) activities, a BAL sample was found to be contaminated with the Mycobacteroides chelonae (NTM) organism. The patient was asymptomatic and no infection was identified; therefore, antibiotics were not administered. There was no delay in the diagnosis related to the nodule biopsy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949024 ↗
• OtherSep 29, 2026Use of Device Problem

  Patient problems: Pneumothorax

  MAUDE report 50936000 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  It was reported that the patient underwent an Ion lung biopsy procedure, and developed a pneumothorax which required hospitalization. The target nodule was located in the right upper lobe along the fissure. The physician believed the pneumothorax may have been caused by the biopsy brush, noting that the brush was inserted too far by the assisting nurse. The physician reported feeling significant resistance upon withdrawal of the brush, which was found to have blood on it upon removal.The pneumothorax was managed conservatively without the need for chest tube placement. The patient's condition improved by the following morning, and the patient was subsequently discharged. It is unknown when and how the pneumothorax was identified.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: Pneumothorax

  MAUDE report 50871182 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  It was reported that during an Ion lung biopsy procedure, the patient had significant bleeding. The target nodule was located in the right upper lobe. The physician addressed the bleeding by tamponading the area and applying cold saline. The patient¿s current status is unknown. There is no allegation that a malfunction of an Ion system, instrument, or accessory occurred.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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50870877 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  It was reported that the patient underwent an Ion lung biopsy procedure, and developed a pneumothorax. The target nodule was located in the right upper lobe. Further details were not provided. There was no device malfunction reported.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: Pneumothorax

  MAUDE report 50841006 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an Ion lung biopsy procedure and developed a pneumothorax which required chest tube placement and hospitalization. The target nodule measured 12 mm and was located in the right upper lobe, 3 mm from the pleural surface. The initial pneumothorax was not considered severe, and the physician elected to continue the procedure. However, a follow-up chest X-ray demonstrated an increase in pneumothorax size, necessitating chest tube placement for resolution.The physician did not attribute the pneumothorax to the Ion system, noting it likely would have occurred via an alternative modality. The procedure had been classified as high risk preoperatively, and the pneumothorax was attributed to the patient's advanced age and significant fibrotic lung disease. No malfunction or device-related issues were identified with the Ion system, instruments, or accessories.

  Patient problems: Pneumothorax

  MAUDE report 50840164 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50831130 ↗
• InjurySep 18, 2026Insufficient Device Problem Information

  It was reported that after Ion endobronchial lung biopsy procedures, an unspecified number of patients returned with infections. The customer reported that there was recent water intrusion in Ion catheters, but it was unknown if these infections were related to Ion catheters. An Intuitive Surgical, Inc. (ISI) Field Service Engineer (FSE) performed a field evaluation, catheter and Flexible Instrument Manipulator (FIM) inspections were performed, and water evidence was found to be present.

  Patient problems: Unspecified Infection

  MAUDE report 50820467 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an Ion transbronchial lung biopsy procedure, the patient experienced a tension pneumothorax. A prior lung resection for lung cancer significantly altered the patient's anatomy, shifting it up and causing the case to be technically more difficult. The physician biopsied a nodule located directly anterior to the heart within a very small remaining portion of lung tissue. The physician only used cryoprobe during the procedure and was reported to have been very careful in confirming positioning throughout. The patient was expected to be hospitalized overnight. Additional information was not provided. Intuitive Surgical Inc. (ISI) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained.

  Patient problems: Pneumothorax

  MAUDE report 50820030 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an Ion microwave ablation procedure, the patient experienced post-ablation syndrome (inflammatory response) that required hospitalization. The post-ablation syndrome was noted to be a possible expected adverse event to the procedure, typically occurring a few days post treatment as the treated necrotic tissue is absorbed and the patients typically present with flu-like symptoms. After the standard one-night stay in the hospital, the medical team decided to keep the patient hospitalized because the patient experienced pain, shortness of breath, and pleural effusion. The patient was treated with unspecified intravenous antibiotic therapy and was hospitalized for 1 week and then discharged in stable condition. It was believed the complication could have possibly occurred via another modality and the adverse event was not deemed to be Ion related and there were no issues with the Ion System.

  Patient problems: Chest Pain; Dyspnea; Pleural Effusion

  MAUDE report 50804501 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumothorax

  MAUDE report 50796925 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an Ion transbronchial lung biopsy procedure, the patient experienced pulseless electrical activity (PEA). Near the end of the case, as the team began extubation, the patient lost pulse, however, no resuscitation measures were required. The biopsy was obtained from the lower lobe, just above the diaphragm. During the procedure, it was noted that the airway looked really big on the spin, but no complication was apparent until the procedure had concluded. The patient was discharged home the same day and was doing well. Per the physician, there was no PEA during bronchoscopy. It was reported that the procedure itself was performed without issue. There was no allegation that a malfunction of an Ion system, instrument, or accessory occurred.Intuitive Surgical, Inc. (ISI) attempted follow-up to obtain additional information; however, the physician did not recall a PEA event.

  Patient problems: Asystole

  MAUDE report 50793858 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an Ion transbronchial lung biopsy procedure, the patient had developed a pneumothorax that required a chest tube. Two nodules were being biopsied and the lesions were 1.7cm located in the right middle lobe (attached to the pleura) and 1.1cm located in the right lower lobe. After biopsying the first nodule, an intraoperative CT scan identified a large pneumothorax, and a 14 gauge chest tube was inserted. The procedure was completed as planned. The physician believed the pneumothorax was caused by a spatial orientation issue and that it could have occurred with another biopsy modality. There were no issues with the Ion System. After the procedure, the patient was hospitalized for 2 days then discharged home. The final diagnosis was non-small cell lung cancer.

  Patient problems: Pneumothorax

  MAUDE report 50789744 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  Patient problems: Pneumothorax

  MAUDE report 50781513 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an Ion transbronchial lung biopsy procedure, the patient developed a pneumothorax. It was unknown if any intervention was performed. There was no allegation that a malfunction of an Ion system, instrument, or accessory occurred. The procedure was completed. Intuitive Surgical Inc. (ISI) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained.

  Patient problems: Pneumothorax

  MAUDE report 50773877 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an Ion transbronchial lung biopsy procedure, the patient developed a pneumothorax. The biopsied lesion measured 3.3 x 2.7 cm and located in the superior segment of the left lower lobe abutting the pleura and fissure. The procedure was completed without complication. However, the physician noted that the needle or forceps may have contacted the fissure or pleura. After the procedure, the patient developed sharp, pleuritic chest pain following a heavy coughing episode. The physician believed the coughing may have induced the pneumothorax. The Ion system did not exhibit any issues that may have contributed and the pneumothorax could have occurred with another biopsy modality. A post-procedure chest X-ray identified the pneumothorax, and a subsequent Computed Tomography (CT) confirmed a moderate-sized pneumothorax. It did not increase in size. A 10 French chest tube was inserted, and the patient received pain control with acetaminophen, opioids, and a lidocaine patch, as well as supplemental oxygen. The patient was admitted for 4 days and 3 nights. The chest tube was removed on day 2, but the patient remained hospitalized longer due to frailty and was then di

  Patient problems: Pneumothorax

  MAUDE report 50773193 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an Ion-assisted lung biopsy procedure, the patient developed a pneumothorax requiring chest tube placement, and the procedure was subsequently aborted. The target nodule measured 1.6 cm and was located in the anterior right upper lobe, adjacent to or continuous with the pleural surface.The pneumothorax was detected via fluoroscopy. Positive end-expiratory pressure (PEEP) was lowered and a chest tube was placed to manage the event. The patient had been admitted to the hospital one week prior to the procedure and remained hospitalized for an additional week following the procedure due to a prolonged air leak, which required chemical pleurodesis.Regarding the procedural approach, tomosynthesis was utilized during the case as it was available on the institution's imaging equipment. When the target was updated using the tomosynthesis signal rather than maintaining the original mapping created in PlanPoint, the guidance and warning information regarding distance to the pleural surface was no longer available to the physician. The physician acknowledged that this loss of pleural proximity data may have been a contributing factor to the pneumothorax, and reflect

  Patient problems: Pneumothorax

  MAUDE report 50771016 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an Ion transbronchial lung biopsy procedure, the patient developed a pneumothorax. Per the physician, the pneumothorax was due to patient factors and not due to Ion System issues. No additional information was provided.

  Patient problems: Pneumothorax

  MAUDE report 50751976 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Metabolic Acidosis

  MAUDE report 50744242 ↗
• InjurySep 11, 2026Insufficient Device Problem Information

  Patient problems: Pneumothorax

  MAUDE report 50740589 ↗
• InjurySep 11, 2026Output Problem

  It was reported that during an Ion lung biopsy procedure, significant intraoperative hemorrhage was encountered and the procedure was aborted. Prior to abortion, biopsy samples were successfully obtained, and the physician was able to establish a diagnosis.Mid-procedure, the Ion system experienced a non-recoverable fault, indicated by a red circle alert on the system display. The system shut down completely, rendering the robotic arm non-functional and preventing controlled retraction of the catheter via the wheel mechanism. The fault occurred during acquisition of additional transbronchial biopsy samples for molecular testing.Significant bleeding was present at the time of the system fault. Estimated blood loss was approximately 400-500 mL. The patient required nearly every available bronchoscopic hemostatic intervention, with the exception of Argon Plasma Coagulation (APC). The patient did not require blood transfusion. Following the procedure, the patient was kept intubated in the intensive care unit (ICU) with an endobronchial blocker in place due to small, ongoing slow hemorrhage.The physician indicated that the Ion system malfunction may have been a contributing factor in the

  Patient problems: Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50736017 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that towards the end of the Ion procedure a patient developed a pneumothorax in the left upper lobe, which was identified via chest X-ray. The patient required the placement of the chest tube and was admitted in the hospital. No additional information surrounding patient status was provided. There were no allegations made against the Ion system or instruments and accessories.Intuitive Surgical Inc. (ISI) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained.

  Patient problems: Pneumothorax

  MAUDE report 50735073 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an Ion endobronchial lung biopsy procedure, the patient developed a pneumothorax requiring a chest tube and hospitalization. The pneumothorax was identified on a post-operative X-ray. The patient was going to be staying in the hospital overnight following chest tube placement. The procedure was completed with no complications and/or delays. There was no allegation that a malfunction of an Ion system, instrument, or accessory occurred.

  Patient problems: Pneumothorax

  MAUDE report 50713325 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an Ion endobronchial lung biopsy procedure, the patient developed a pneumothorax in the left upper lobe (LUL) requiring a chest tube and hospitalization. Per the physician, there were no issues with the Ion System and the biopsy itself caused the pneumothorax.

  Patient problems: Pneumothorax

  MAUDE report 50690757 ↗