St. Jude Medical Agilis NxT Steerable Introducer recall
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Why was St. Jude Medical Agilis NxT Steerable Introducer recalled?
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05414734206099, Lot Number 10071090
- Product
- St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
- Recalling firm
- St. Jude Medical
- Quantity
- 129 units
- Distribution
- US and Canada
- Recall date
- July 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)