IonRecalls & reported problems across all models

We found 6 models of Ion by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,367 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2020 and Sep 30, 2026 — classified as 97 deaths, 1,186 injuries, 83 malfunctions.

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

3 FDA recall records name at least one of these models by its device identifier, 2 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. 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

Ion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 4, 2025Open, Classified

   Due to probe bags that may have a compromised or incomplete sterile pouch seal.

   Z-1134-2026 · Root cause: Process control · Recall details · FDA record ↗

2. 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 ↗

3. 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 · Recall details · FDA record ↗

Most reported Ion problems

Ion models

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

• Ion 380748

  Bronchoscope (flexible or rigid)
  1 recall97 deaths1,278 reports
• Ion 490105

  Bronchoscope (flexible or rigid)
  1 recall26 reports
• Ion 490127

  Drape, surgical, exempt
  1 recall0 reports
• Ion 490305

  Bronchoscope (flexible or rigid)
  29 reports
• Ion 490206

  Bronchoscope (flexible or rigid)
  24 reports
• Ion 380707

  Bronchoscope (flexible or rigid)
  10 reports

Recent Ion adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 28, 2026Unintended Movement

  Patient problems: Insufficient Information

  MAUDE report 50923766 ↗
• 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 ↗
• MalfunctionSep 22, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that during an Ion Endoluminal Lung Biopsy, the fully articulating catheter reportedly exploded in the nursing assistant's hands during the pre-disinfection step. No patient involvement.Intuitive Surgical (IS) obtained the following additional information regarding this event: It was confirmed that the nurse did not suffer any injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851999 ↗
• 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 ↗
• MalfunctionSep 19, 2026Device Reprocessing Problem

  Patient problems: Insufficient Information

  MAUDE report 50832263 ↗
• 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 ↗

Other Intuitive Surgical, Inc. products

• EndoWrist62 models · 69,753 reports · 48 recalls
• daVinci Xi4 models · 11,477 reports · 3 recalls
• EndoWrist;daVinci Si35 models · 1,683 reports · 8 recalls
• daVinci 53 models · 1,608 reports · 5 recalls
• da Vinci Surgical System9 models · 1,459 reports · 5 recalls
• SureForm16 models · 1,190 reports · 3 recalls
• EndoWrist SP20 models · 993 reports · 1 recall
• daVinci Si8 models · 681 reports · 1 recall