Intuitive Surgical Recalls 8mm Cardiac Probe Grasper Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Cardiac Probe Graspers because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
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 is classified as FDA Class II. The hazard involves mechanical wear and surface degradation of a surgical instrument, which poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of the 8mm Cardiac Probe Grasper. These instruments are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall involves all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings, specifically part number 470215-04.
The recall is due to deviations in reprocessing steps from those stated in the reprocessing instructions. These deviations can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. The affected devices were distributed in the United States to facilities in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
Healthcare facilities should stop using the affected instruments and contact Intuitive Surgical for further instructions on reprocessing or replacement.
The recalled product
- Product
- 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 509
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)
- Part number
- 470215-04
Distribution
Part of a larger recall action
This product is one of 22 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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