Intuitive Surgical Recalls 5 mm Thoracic Grasper Due to Coating Damage
Intuitive Surgical is recalling 2,436 units of 5 mm Thoracic Graspers because coating damage could cause fragments to fall into patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where a defect could cause foreign material to enter a patient, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 2,436 units of the 5 mm Thoracic Grasper, intended for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. The recall covers version 420343-01 and 420323-02, all lots. The product was distributed worldwide, including in the US, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and the United Kingdom.
The recall is due to a potential defect where the coating of the 5 mm Thoracic Grasper main tube may experience damage. This damage creates the possibility that fragments of coating material could dislodge and potentially fall into the patient during use.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 2,436
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 (2)
- version 420343-01 and 420323-02
- all lots
Distribution
Distribution scope not specified by the agency.
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