Boston Scientific recalls Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM with sterile barrier breach. Affected units have specific lot numbers and material codes. Stop using immediately to prevent infection risks.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling Dreamtome Cannulating Sphincterotome devices due to a sterile barrier breach that could compromise sterility. This poses a risk of infection during medical procedures if the device is used without proper sterility.
The device has a sterile barrier that can be breached, leading to contamination. This breach could compromise the sterility of the device during medical procedures, increasing the risk of infection for patients.
Medical professionals using the Dreamtome Cannulating Sphincterotome device are affected. Patients undergoing procedures with this device are at risk of infection if the device is not sterile.
Check for the material number M00584060 and lot numbers listed: 27463326, 27468730, 27553568, 27590928, 27629941, 27684747, 27764231, 27794744, 27837500, 27931763, 27986550, 28058938. The device is sold under GTIN 8714729778288.
Discard the Dreamtome Cannulating Sphincterotome device if you have it, as it may be contaminated.
The material number is M00584060.
Affected lot numbers include 27463326, 27468730, 27553568, 27590928, 27629941, 27684747, 27764231, 27794744, 27837500, 27931763, 27986550, and 28058938.
Check the material number (M00584060) and lot numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0752-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0752-2022 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.
