Boston Scientific recalls Encore 26 Inflation Devices with specific model numbers due to risk of foreign material particles migrating into balloon catheters during use.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Boston Scientific is recalling certain Encore 26 Inflation Devices because foreign material particles can migrate into balloon catheters during use. This could potentially cause complications during medical procedures if the device is used without proper cleaning or maintenance.
The device can allow foreign particles to migrate into balloon catheters during use. This migration could lead to complications if the device is not properly cleaned or maintained before use.
Patients and medical professionals using the recalled Encore 26 Inflation Devices for balloon dilation procedures are affected. Those with the specific model numbers listed in the recall are most at risk.
Check for the model numbers listed: H74904526011, H74904526052, M0067101140, M001151050, M001151062, or M00566670. These devices were sold to interventional cardiology and peripheral interventions departments.
Identify the model number on your device to see if it matches the recalled numbers.
Reach out to Boston Scientific for further guidance on the recall process.
The affected model numbers are H74904526011, H74904526052, M0067101140, M001151050, M001151062, and M00566670.
The recall record does not specify a remedy.
Check the model number on your device against the list: H74904526011, H74904526052, M0067101140, M001151050, M001151062, or M00566670.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2533-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2533-2025 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.
