Intuitive Surgical, Inc. Recall 95938
Description: 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Intuitive Surgical, Inc. Recall 95938 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0849-2025 |
| Event ID | 95938 |
| Event Description | 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 |
| Product Type | Devices |
| 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 |
| Quantity | 10,603 |
| Recall Reason | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Device Classification | 20250122 |
| Device Code Info | Model Number: 470006 Part Number: 470006-12 UDI-DI code: 00886874112151 Batch Numbers: K10230120 K10230118 K12230119 K11230118 K10230217 Part Number: 470006-13 UDI-DI code: 00886874112151 Batch Numbers: K10230623 K10240506 K10240815 |
| Center Classification Date | 20250110 |
| Recall Initiation Date | 20241219 |
| Recalling Firm | Intuitive Surgical, Inc. |
| Initial Notification | Letter |
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