St. Jude Medical recalls Agilis NxT Steerable Introduer model REF 408309 with short dilators that may not extend outside the sheath, posing a risk of injury during medical procedures.
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
St. Jude Medical is recalling a specific model of steerable introducer used in medical procedures because one lot has dilators that are too short and won't extend outside the introducer sheath. This could cause injury during medical procedures if the dilators cannot properly extend.
The dilators in this specific lot are too short to extend outside the introducer sheath. This means they may not properly advance during medical procedures, potentially causing injury to the patient or the medical professional.
Medical professionals who use the St. Jude Medical Agilis NxT Steerable Introducer with the specific lot number 10071090 are affected. Patients undergoing procedures with this device may be at risk if the dilators cannot extend properly.
Check the product label for the model reference 408309 and lot number 10071090. The device is sold under the brand St. Jude Medical.
Look for the model reference 408309 and lot number 10071090 on the device label.
St. Jude Medical recalls this specific model because one lot has dilators that are too short and may not extend outside the introducer sheath, which could cause injury during medical procedures.
The official recall notice does not specify a remedy or action steps beyond checking the device label for the model and lot numbers.
The recall indicates that this specific lot number may not be safe to use as the dilators could not extend properly, posing a risk of injury.
We’ve drafted a message you can send St. Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2348-2024 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-2348-2024 from St. Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
