Intuitive Surgical Recalls Ion Catheter Reprocessing Covers
Intuitive Surgical is recalling 67 Ion Catheter Reprocessing Covers because they may fail to engage correctly, potentially causing catheter or system failure.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device failure) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 67 units of the Ion Catheter Reprocessing Cover, IF1000 (Part Number: 490114-02). The recall covers all lots of this specific part number.
The recall was initiated because the covers have the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter. This malfunction 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 units 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 were no foreign consignees.
The recalled product
- Product
- Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 67
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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