Intuitive Surgical, Inc. INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
Lot Number: 802011
Products Sold
Lot Number: 802011
Intuitive Surgical, Inc. is recalling INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, due to The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
Recommended Action
Per FDA guidance
On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026