Intuitive Surgical, Inc. recalls Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic mani…
- Recall date
- May 21, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1812-2015
- FDA classification
- Class II
- Brand / firm
- Intuitive Surgical, Inc.
- Sold / distributed
- Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
Why it was recalled
The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
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