The Recall Desk

FDA (Devices) recall action 85256

Intuitive Surgical, Inc. recalled 2 products on 2020-05-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-05-13
Critical
0
Units
22,752

Why these products were recalled

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-05-13

    Intuitive Surgical Recalls daVinci XI Sureform 60 Reloads Due to Staple Deployment Issues

    Intuitive Surgical is recalling specific daVinci XI Sureform 60 Reloads because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

    Product
    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
    Category
    Distribution
    44 states
  • HighFDA (Devices)··2020-05-13

    Intuitive Surgical Recalls daVinci XI Sureform Stapler Reloads Due to Deployment Defect

    Intuitive Surgical is recalling 22,752 daVinci XI Sureform 60 reloads worldwide because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

    Product
    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, Gynecologi
    Category
    Distribution
    44 states