Medical Device: Ion Endoluminal System Recalled for Instrument Arm Screw Failure
Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.
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: FDA Class II recall with potential for serious harm (uncontrolled catheter motion in patient airways). The source text does not report any injuries or adverse events, placing this in the High category for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Ion Endoluminal System (Model REF: 380748-65). The instrument cart arm may contain screws that could fail, potentially resulting in uncontrolled motion of the catheter inside a patient's airways during a procedure.
The recall affects 3 systems with the following identifiers: System EN1230/Cart 10591271, System EN1241/Cart 10591273, and System EN1231/Cart 10583014. These units were distributed in Arizona and California.
Patients and healthcare providers with these systems should contact Intuitive Surgical, Inc. for further information and guidance on next steps.
The recalled product
- Product
- Ion Endoluminal System, REF: 380748-65
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 3
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)
- EN1241/10591273
- EN1231/10583014
Distribution
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