Summary
The FDA issued a Class II for 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 by Intuitive Surgical, Inc.. Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws..
Details
Source
Device Recall
External ID
Z-0882-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Lot/Code Info: Model Number: 471400 Part Number: 471400-10 UDI-DI code: 00886874121528 Batch Numbers: K10221106 K10221212 K10230129 K10230205 K10230212 K10230219 K10230226 K10230413 K10230504 K10230515 K10230518 K10230525 K10230601 K10230608 K10230615 K10230630 K10230713 K10230720 K10230817 K10230824 K10230831 K10230913 K10230917 K10230928 K10231005 K10231012 K10231019 K10231027 K10231102 K10231130 K10231218 K10240104 K10240116 K10240208 K10240322 K10240327 K10240404 K10240411 K10240516 K10240523 K10240606 K10240613 K10240618 K11221106 K11230129 K11230515 K11230824 K11231012 K11240104 K11240404 K11240702
Quantity Affected: 14,507
Reason for Recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-19
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intuitive Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0882-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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