daVinci XiRecalls & reported problems across all models

We found 4 models of daVinci Xi by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 11,477 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2016 and Sep 30, 2026 — classified as 239 deaths, 1,227 injuries, 10,009 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (3,664 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

daVinci Xi 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. Jan 24, 2023Open, Classified

   Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

   Z-1262-2023 · Root cause: Component change control · Recall details · FDA record ↗

2. Sep 20, 2022Open, Classified

   Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

   Z-0133-2023 · Root cause: Software Design Change · names 3 of these models · Recall details · FDA record ↗

3. Jul 16, 2018Terminated

   Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

   Z-3254-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported daVinci Xi problems

daVinci Xi models

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

• daVinci Xi 380652

  System,surgical,computer controlled instrument
  2 recalls235 deaths5,316 reports
• daVinci Xi 381121

  System,surgical,computer controlled instrument
  1 recall2 deaths4,310 reports
• daVinci Xi 380677

  System,surgical,computer controlled instrument
  2 recalls2 deaths1,849 reports
• daVinci Xi 380799

  System,surgical,computer controlled instrument
  2 reports

Recent daVinci Xi adverse event reports

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

• MalfunctionSep 30, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955020 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954542 ↗
• MalfunctionSep 30, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50954384 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50953996 ↗
• MalfunctionSep 30, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953889 ↗
• MalfunctionSep 30, 2026Optical Discoloration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953887 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953880 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  Patient problems: Insufficient Information

  MAUDE report 50953744 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953600 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50953593 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953500 ↗
• MalfunctionSep 30, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952349 ↗
• MalfunctionSep 30, 2026Unintended System Motion

  It was reported that during a da Vinci-assisted surgical procedure, the arms on the Surgeon Side Console (SSC) moved or drifted when the Surgeon logged on. The customer was unsure if the arms on the Patient Side Cart (PSC) moved. The customer was concerned there was something wrong and power cycled the system prior to calling into Technical Support. The Technical Service Engineer (TSE) noted the logs were not available. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951931 ↗
• MalfunctionSep 30, 2026Output Problem

  It was reported that prior to starting a da Vinci-assisted surgical procedure, the customer encountered an error 32056 on the Universal Surgical Manipulator 4 (USM4). The Technical Service Engineer (TSE) had the customer emergency power off the Patient Side Cart but the error remained. The TSE advised the customer to disable the USM4, the customer stated that they would confirm with the surgeon that the case could be completed with three Universal Surgical Manipulator (USM)s. The procedure was completed with no reported injury.

  Patient problems: Insufficient Information

  MAUDE report 50942442 ↗
• MalfunctionSep 30, 2026No Device Output; Visual Prompts will not Clear

  It was reported that the Universal Surgical Manipulator (USM) 1 had a non-recoverable fault 32056 when the system powered on. The customer power cycled the system five times, but the issue remained. The Intuitive Surgical, Inc. (ISI) Technical Service Engineer had the customer hard power cycle the system, but the error returned again. There was no report of patient involvement.ISI contacted the Clinical Territory Associate and obtained the following information: The issue was identified when setting up the Operating Room (OR) in the evening on the 6th to get the system ready for the next day. The two patients (procedures) were cancelled and are being rescheduled. No procedure was going on at the time of the event. The robot was isolated until a Field Service Engineer (FSE) was able to go on site. There was no delay involved, just cancellation of upcoming procedures. There was no injury to any patient. The FSE resolved the issue on the afternoon of the 7th.ISI contacted the Technical Support Engineer and obtained the following information: With error 32056, the customer could have used the system and proceeded with the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50942438 ↗

Other Intuitive Surgical, Inc. products

• EndoWrist62 models · 69,753 reports · 48 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
• Ion6 models · 1,367 reports · 3 recalls
• SureForm16 models · 1,190 reports · 3 recalls
• EndoWrist SP20 models · 993 reports · 1 recall
• daVinci Si8 models · 681 reports · 1 recall