Single-Site recallZ-0406-2024 · Intuitive Surgical, Inc. · initiated Oct 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
FDA root cause category: Process control
What the company is doing
On October 24, 2023, Intuitive issued a "Urgent Medical Device Recall notification" to all affected consignees via E.Mail. Intuitive asked consignees to take the following actions: 1. Read and understand the contents of the letter. 2. Locate and return all affected lots of 478115-03 in your inventory via the standard RMA process by calling Intuitive Customer Service based on your region below. 3. Notify all surgeons, personnel, and sites using da Vinci X and da Vinci Xi Single Site Wristed Needle Driver, PN 478115-03 that they should review and understand the contents of this letter. 4. Complete the attached Acknowledgement Form immediately and return it via email to Intuitive as instructed on the form. a. Please retain a copy of this letter and the acknowledgement form for your files. 5. Inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject device via the standard complaint process. 6. For Customers in the US: 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. a. Complete and submit the report Online Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. 8. Inform all affected personnel at your site who use da Vinci procedures when the return has been completed.
Recall details
- Recall number
- Z-0406-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 6, 2023
- Posted by the FDA
- Nov 28, 2023
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 317 units
- Product code
- NAY
- FDA submissions
- K152448
- Distribution
- US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
Product description
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Code information (models, lots, serial numbers)
UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Single-Site 478115Intuitive Surgical, Inc. · Laparoscope, general & plastic surgery1 recall61 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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