8MM Dual Blade Retractor (Intuitive Surgical) – Grip Cable Failure (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: 470249 Part Number: 470249-09 UDI-DI code: 00886874112403 Batch Numbers: K10230226 K10230316 K10230323 K10230331 K10230518 K10230824 K10230831 K10231130 K10231214 K10240118 K10240208 K10240222 K10240327 K10240509 K10240711 K10240725 K10240801 K11231116
Intuitive Surgical, Inc. is recalling 8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249 due to Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Recommended Action
Per FDA guidance
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)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026