Intuitive Surgical Recalls ION Reprocessing Accessories Kit Due to Catheter Failure Risk
Intuitive Surgical is recalling 27 units of the ION Reprocessing Accessories Kit because the catheter reprocessing cover may disengage, causing chemical retention and system failure.
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 and involves a risk of harm (system failure and chemical retention) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 27 units of the ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03). The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02). The recall affects all lots of this specific product.
The recall is being issued because one type of the ION Catheter Reprocessing Covers has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter. This defect can result in the retention of cleaning chemical or water during reprocessing, which may cause failure of the ION Fully Articulating Catheter or the ION System.
The affected products were distributed in the United States to facilities in California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. There are no foreign consignees. Users should stop using the affected kits and contact Intuitive Surgical for instructions on replacement or return.
The recalled product
- Product
- ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 27
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 (1)
- All lots.
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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