FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194
- Recall number
- Z-0858-2025
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194
- Status
- Open, Classified
- Initiated
- 2024-12-19
- Posted
- 2025-01-10
- Terminated
- not on file
- Reason
- Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Root cause
- Process change control
- Action
- On 12/19/2024, the firm send via email an "Urgent: Medical Device Correction" Letter informing customer that Intuitive Surgical has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci X and Xi reusable instruments. Customer are instructed to: 1. Customers can continue using the products in accordance with the user manual. 2. As a reminder, when using da Vinci X and Xi reusable instruments, follow the Inspection Before Use and Warnings listed in the manual provided with your system to inspect for any broken cables. Refer to Figures C and D for examples. In addition, please refer to Appendix B for additional images for detection of grip cable failures. 3. If you observe any failed (frayed or broken) grip cables prior to use, during procedure, or during reprocessing, please stop use of instrument, remove from use and inform Intuitive via the standard complaint process. 4. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject device via the standard complaint process. For Question and assistance - " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
- Quantity
- 38,438
- Distribution
- U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam
- Lot, serial or model codes
- Model Number: 470194 Part Number: 470194-06 UDI-DI code: 00886874112342 Batch Numbers: K10221113 K10221128 K10221204 K10221212 K10221218 K10230112 K10230205 K10230212 K10230217 K10230824 K10240418 K10240502 K10240523 K10240718 K10240801 K11221212 K11230112 K11230217 K11240418 K12230112 K12230217 K16240702 U10230217 Model Number: 470194 Part Number: 470194-08 UDI-DI code: 00886874112342 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230405 K10230420 K10230511 K10230525 K10230601 K10230608 K10230615 K10230622 K10230706 K10230713 K10230720 K10230727 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231214 K10240104 K10240111 K10240118 K10240125 K10240202 K10240208 K10240215 K10240314 K10240327 K10240404 K10240425 K10240509 K10240515 K10240523 K10240606 K10240613 K10240620 K10240627 K10240702 K10240822 K11230302 K11230310 K11230323 K11230720 K11230727 K11230914 K11231012 K11231027 K11231109 K11240118 K11240125 K11240314 K11240404 K11240509 K11240620 K11240822 K12230302 K12230914 K12240404 K12240509 K12240620 U10230517
- 510(k) numbers
- ["K150284"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28