Boston Scientific recalls Dreamtome RX Cannulating Sphincterotome with sterile barrier breach risk. Affected units have specific batch numbers and material codes. Contact for remedy.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling Dreamtome RX Cannulating Sphincterotome devices due to a sterile barrier breach that compromises device sterility. This could lead to infections during medical procedures if the device is used without proper sterility.
The device has a sterile barrier breach, meaning it may not be sterile when used. This could lead to infections during medical procedures if the device is used without proper sterility checks.
Medical professionals using the Dreamtome RX Cannulating Sphincterotome device are most at risk. Patients undergoing procedures with this device may be affected if sterility is compromised.
Check for the model name 'Dreamtome RX Cannulating Sphincterotome' and material number M00584040. Affected units have specific batch numbers listed in the recall notice.
Verify the device has the material number M00584040 and one of the listed batch numbers to confirm it is affected.
The recall states the device may have a sterile barrier breach, so it is not safe to use without proper sterility checks.
Check the device for the material number M00584040 and batch numbers listed in the recall notice to determine if it is affected.
The recall record does not specify a remedy or replacement process.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0751-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0751-2022 from Boston Scientific. 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.
