8MM Fenestrated Bipolar Forceps (Intuitive Surgical) – Grip Cable Failure (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: 470205 Part Number: 470205-17 UDI-DI code: 00886874112359 Batch Numbers: K10221204 K10221218 K10230103 K10230219 K10230226 K10230310 K10230316 K10230323 K10230330 K10230405 K10230413 K10230420 K10230504 K10230526 K10230601 K10230615 K10230622 K10230629 K10230817 K10230824 K10230913 K10230921 K10230928 K10231019 K10231027 K10231102 K10231109 K10240129 K10240201 K10240222 K10240229 K10240307 K10240314 K10240321 K10240327 K10240404 K10240411 K10240502 K10240516 K10240523 K10240801 K11230316 K11230413 K11231116 K11240201 K11240327 K15240516
Intuitive Surgical, Inc. is recalling 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205 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