EndoWristRecalls & reported problems across all models
Intuitive Surgical, Inc. · 62 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
44 open recalls name at least one EndoWrist model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 69,753
- Deaths reported
- 27
- Injuries reported
- 2,643
- Recalls
- 48
We found 62 models of EndoWrist by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 69,753 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Sep 30, 2026 — classified as 27 deaths, 2,643 injuries, 67,076 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (34,997 reports).
48 FDA recall records name at least one of these models by its device identifier, 44 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
Reports received per month, all models
EndoWrist 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.
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0883-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0882-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0881-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0880-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0879-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0878-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0877-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0876-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0875-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0874-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0873-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0872-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0871-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0870-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0869-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0868-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0867-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0866-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0865-2025 · Root cause: Process change control · names 2 of these models · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0864-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0863-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0862-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0861-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0860-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0859-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0858-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0857-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0856-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0855-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0854-2025 · Root cause: Process change control · Recall details · FDA record ↗
…and 18 older recalls, listed on each model's page.
Most reported EndoWrist problems
Device problems
- Material Split, Cut or Torn34,997
- Material Frayed7,603
- Material Fragmentation6,123
- Difficult to Open or Close4,299
- Detachment of Device or Device Component3,802
- Break3,647
- Thermal Decomposition of Device2,033
- No Apparent Adverse Event1,772
Patient problems
- No Clinical Signs, Symptoms or Conditions53,392
- Insufficient Information13,829
- No Known Impact Or Consequence To Patient957
- Foreign Body In Patient803
- Unspecified Tissue Injury411
- Hemorrhage/Blood Loss/Bleeding390
- Device Embedded In Tissue or Plaque119
- Burn(s)43
EndoWrist models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EndoWrist 471205System, surgical, computer controlled instrument1 recall14,225 reports
- EndoWrist 470179System,surgical,computer controlled instrument2 recalls2 deaths10,156 reports
- EndoWrist 471093System, surgical, computer controlled instrument1 recall8,581 reports
- EndoWrist 471172System, surgical, computer controlled instrument1 recall1 death6,302 reports
- EndoWrist 471405System, surgical, computer controlled instrument1 recall1 death3,770 reports
- EndoWrist 470327System,surgical,computer controlled instrument2 recalls2,273 reports
- EndoWrist 471049System, surgical, computer controlled instrument1 recall1 death2,253 reports
- EndoWrist 471309System, surgical, computer controlled instrument1 recall2,244 reports
- EndoWrist 470347System,surgical,computer controlled instrument2 recalls2,082 reports
- EndoWrist 470205System,surgical,computer controlled instrument1 recall1,955 reports
- EndoWrist 470230System,surgical,computer controlled instrument2 recalls1,792 reports
- Endowrist 480422System, surgical, computer controlled instrument1 recall11 deaths1,790 reports
- EndoWrist 470183System,surgical,computer controlled instrument3 deaths1,553 reports
- EndoWrist 471296System, surgical, computer controlled instrument1 recall1,392 reports
- EndoWrist 470207System,surgical,computer controlled instrument2 recalls1,336 reports
- EndoWrist 470318System,surgical,computer controlled instrument2 recalls1,117 reports
- EndoWrist 471006System, surgical, computer controlled instrument1,115 reports
- EndoWrist 470194System,surgical,computer controlled instrument1 recall1,043 reports
- EndoWrist 471400System, surgical, computer controlled instrument1 recall1,023 reports
- EndoWrist 470172System,surgical,computer controlled instrument1 recall2 deaths755 reports
- EndoWrist 470184System,surgical,computer controlled instrument708 reports
- EndoWrist 470006System,surgical,computer controlled instrument1 recall289 reports
- EndoWrist 470049System,surgical,computer controlled instrument1 recall239 reports
- EndoWrist 471344System, surgical, computer controlled instrument1 recall233 reports
- EndoWrist 470405System, surgical, computer controlled instrument2 recalls135 reports
- EndoWrist 470401System,surgical,computer controlled instrument2 recalls132 reports
- EndoWrist 470093System,surgical,computer controlled instrument1 recall171 reports
- EndoWrist 480299System,surgical,computer controlled instrument1 recall158 reports
- EndoWrist 470296System,surgical,computer controlled instrument2 recalls103 reports
- EndoWrist 470298System,surgical,computer controlled instrument1 recall2 deaths134 reports
- EndoWrist 470530System,surgical,computer controlled instrument2 deaths136 reports
- EndoWrist 470033System,surgical,computer controlled instrument2 recalls29 reports
- EndoWrist 470400System,surgical,computer controlled instrument111 reports
- EndoWrist 470344System,surgical,computer controlled instrument1 recall42 reports
- EndoWrist 470309System,surgical,computer controlled instrument1 recall26 reports
- EndoWrist 470001System,surgical,computer controlled instrument1 recall25 reports
- EndoWrist 471190System, surgical, computer controlled instrument1 recall23 reports
- EndoWrist 470246System,surgical,computer controlled instrument1 recall22 reports
- EndoWrist 470381System,surgical,computer controlled instrument1 recall20 reports
- EndoWrist 470036System,surgical,computer controlled instrument1 recall19 reports
- EndoWrist 470007System,surgical,computer controlled instrument1 recall15 reports
- EndoWrist 470249System,surgical,computer controlled instrument1 recall14 reports
- EndoWrist 48645BSTAPLE, IMPLANTABLE1 recall1 death14 reports
- EndoWrist 470171System,surgical,computer controlled instrument1 recall10 reports
- EndoWrist 48445GSTAPLE, IMPLANTABLE1 recall10 reports
- EndoWrist 471171System, surgical, computer controlled instrument1 recall10 reports
- EndoWrist 470181System,surgical,computer controlled instrument1 recall3 reports
- EndoWrist 480322System,surgical,computer controlled instrument36 reports
- EndoWrist 48630WSTAPLE, IMPLANTABLE1 death31 reports
- EndoWrist 48630GSTAPLE, IMPLANTABLE30 reports
- EndoWrist 410370System,surgical,computer controlled instrument18 reports
- EndoWrist 470430System,surgical,computer controlled instrument14 reports
- EndoWrist 471048System, surgical, computer controlled instrument10 reports
- EndoWrist 470190System,surgical,computer controlled instrument7 reports
- EndoWrist 48645WSTAPLE, IMPLANTABLE4 reports
- EndoWrist 48630BSTAPLE, IMPLANTABLE3 reports
- EndoWrist 470545System,surgical,computer controlled instrument3 reports
- EndoWrist 470048System,surgical,computer controlled instrument2 reports
- EndoWrist 470215System,surgical,computer controlled instrument2 reports
- EndoWrist 41645BSTAPLE, IMPLANTABLE2 reports
- EndoWrist 48630MSTAPLE, IMPLANTABLE2 reports
- EndoWrist 41445GSTAPLE, IMPLANTABLE1 report
Recent EndoWrist adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954554 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954551 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954549 ↗MalfunctionSep 30, 2026Entrapment of Device; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954548 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954546 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50954545 ↗MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50954544 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954543 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954386 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954358 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954349 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954342 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954338 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954335 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954331 ↗
Other Intuitive Surgical, Inc. products
- 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
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page