Intuitive Surgical, Inc.: Medical Device Recalls in 2020

According to to data from the FDA, there were 18 medical device recalls made by Intuitive Surgical, Inc. in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
• Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
• da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
• The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.
• daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
• da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
• Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
• da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
• STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
• daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
• STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
• da Vinci Xi Surgical System
• da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
• da Vinci X Surgical System
• da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
• da Vinci SP surgical system
• Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
• da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.