da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
FDA Recall Z-1906-2020 · Posted None
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2018-10-25
Date Terminated2024-04-05
Product Quantity1818 pouches
Reason for Recall
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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