da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch recallZ-1906-2020 · Intuitive Surgical, Inc. · initiated Oct 25, 2018
Terminated
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
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
FDA root cause category: Device Design
What the company is doing
On 10/25/2018, the firm sent an "Urgent Medical Device Correction" Notification Letter to Customers via FedEx (to OUS customers - emailed and hand-delivered) are asked to take actions during draping to avoid snagging the drape during installation and to continue following the instructions in the System User Manual. Representatives will be available by phone to answer questions related to the device correction. Acknowledgement form included with the recall letter is requested to be completed and returned to ISI asking that appropriate personnel be informed about the device correction.
Recall details
- Recall number
- Z-1906-2020
- Status
- Terminated
- Initiated by the company
- Oct 25, 2018
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 1818 pouches
- Product code
- NAY
- FDA submissions
- K173906
- Distribution
- Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea
Product description
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Code information (models, lots, serial numbers)
Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- None 430013Intuitive Surgical, Inc. · System, surgical, computer controlled instrument2 recalls139 reports
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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