Agilis NxT Steerable Introducer Recalled for Dilators Too Short
St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.
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: This is a Class II recall of a medical device with a functional defect that prevents proper operation. No illnesses or injuries have been reported. The defect represents a risk-of-harm situation in a surgical device.
Plain-English summary
St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer (REF 408309) from one lot. The affected units contain dilators that are too short and will not extend outside the introducer sheath.
This defect prevents the dilators from operating as designed, potentially affecting the device's functionality and proper placement.
The recalled units were distributed in the United States and Canada. The recalled lot number is 10071090 (UDI/DI 05414734206099).
Customers who have received or used units from this lot should contact St. Jude Medical for further instructions regarding return or replacement.
The recalled product
- Product
- St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
- Manufacturer
- St. Jude Medical
- Category
- Medical Device
- Affected units
- 129
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)
- UDI/DI 05414734206099
- Lot Number 10071090
Distribution
Distribution scope not specified by the agency.
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