Boston Scientific recalls specific Encore Advantage Kit models due to potential foreign material particles migrating into balloon catheters during use. Affected units include material numbers H74904527011 and H74904527052 with listed lot numbers.
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 Advantage Kits that may allow foreign particles to migrate into balloon catheters during procedures. This could pose a risk of contamination during medical treatments.
Foreign material particles can migrate from affected Encore 26 Inflation Devices into balloon dilatation catheters during use. This could lead to contamination of the catheter during medical procedures, potentially causing complications.
Medical professionals using the Encore 26 Inflation Device with balloon dilation catheters are most at risk. Patients undergoing procedures with these kits may be affected if the device is compromised.
Check for material numbers H74904527011 or H74904527052 on the kit. The kit was sold with specific lot numbers listed in the recall notice for interventional cardiology and peripheral interventions.
Review the material numbers and lot numbers on the kit to confirm if it is affected.
The recalled kits have material numbers H74904527011 and H74904527052.
Lot numbers for H74904527011 include 34783060, 34849364, 34873499, 34942522, 34976509, 35017763, 35065979, 35067000. Lot numbers for H774904527052 include 34873681, 34915075, 34942524, 34986473, 34986475.
The recall record does not specify a remedy or action for the affected kits.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2534-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2534-2025 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.
