Recall
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X…
Intuitive Surgical, Inc. · 7 Oct 2022
- Status
- Recall open, classified
- Why, in the FDA's words
- “Potential staple deployment failure and device fragment generation”
- Recall began
- 7 Oct 2022
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K211997
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.