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FDA-Device2026-07-01Class IIPROCESSING DEFECT

Intuitive Surgical Da Vinci surgical system recalled for E-brake failure risk

Intuitive Surgical
Nationwide distributiondevice

Intuitive Surgical Da Vinci recalled for E-brake failure risk

Certain Da Vinci surgical systems were distributed with a defective E-brake retainer pin. If the structural column fails, this pin can prevent the E-brake from engaging, potentially causing uncontrolled motion of the robotic arm. The pin may also loosen or back out, restricting arm movement or causing uncontrolled motion that could injure patient tissue.

  • If you operate or maintain a Da Vinci system, check the serial number against the FDA's list of affected units.
  • Contact Intuitive Surgical immediately if your system is affected.
  • Do not use an affected system until you receive repair instructions from the manufacturer.
  • Report any injuries or device malfunctions to the FDA's MedWatch program.
Hazard

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Who it affects
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania.
Affected count
454
Manufactured in
1266 Kifer Rd, N/A, Sunnyvale, CA, United States
Products
Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2026

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