St. Jude Medical recalls specific Agilis NxT Steerable Introducer models due to inadequate seal from lack of adhesive glue. Affected units include model STJ408309 and others with expiration dates prior to 05/31/2018.
Inadequate seal due to lack of adhesive glue
St. Jude Medical is recalling certain Agilis NxT Steerable Introducer catheters because they may not seal properly due to insufficient adhesive glue. This could lead to leaks during medical procedures, potentially causing complications for patients.
The catheters lack proper adhesive glue, which can cause the seal to fail during medical procedures. This might lead to leaks or fluid escape, potentially causing complications like infections or bleeding.
Healthcare professionals using the recalled catheters for heart procedures are most at risk. Patients undergoing these procedures with the affected devices may experience complications.
Check for model numbers STJ408309, STJ408310, or STJ408324 on the device. The expiration date should be prior to May 31, 2018. All affected lots are listed in the recall notice.
Look for model numbers STJ408309, STJ408310, or STJ408324 on the catheter.
Ensure the expiration date is prior to May 31, 2018.
The recalled models are STJ408309, STJ408310, and STJ408324.
The product was manufactured with an expiration date prior to May 31, 2018.
Check the model number on the device and ensure the expiration date is prior to May 31, 2018. Affected lots are listed in the recall notice.
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-0213-2018 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-0213-2018 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.
