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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to an anastomotic leak requiring additional procedural intervention, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling specific lots of the daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm (Ref: 48360T-08). The affected product is a sterile, prescription-only surgical stapler reload intended for use with da Vinci Surgical Systems for resection, transection, or creation of anastomoses in general, thoracic, gynecologic, urologic, and pediatric surgery.
The recall was initiated due to a manufacturing variation where black and green reloads in select Stapler Reloads may not deploy individual adjacent staples. This defect could result in an incomplete staple line. An incomplete staple line could potentially lead to an air leak or an anastomotic leak, which may require an additional procedural intervention.
The affected lots are T10180615, T10180924, T10181003, T11181003, T10181010, T10181016, T10181029, T10181107, T10181109, and T10181113. The products were distributed worldwide, including nationwide in the United States and in several countries in Europe, Asia, and Australia. Healthcare providers should check their inventory for these specific lot numbers and contact the manufacturer for instructions on how to return or dispose of the affected units.
The recalled product
- 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
- Manufacturer
- Intuitive Surgical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot numbers: T10180615
- T10180924
- T10181003
- T11181003
- T10181010
- T10181016
- T10181029
- T10181107
- T10181109
- T10181113
Distribution
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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