Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential polyurethane layer delamination causing guidewire advancement issues. Affected units have specific batch numbers and reference codes.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to reports of polyurethane layer delamination that may prevent guidewire advancement. This could lead to medical complications during procedures if the catheter fails to function properly.
The catheters may experience polyurethane layer delamination in some batches, causing material detachment in the inner lining. This can make it difficult to advance the guidewire through the device, potentially leading to procedural complications.
Cardiologists and medical professionals using the recalled catheters for cardiac procedures. Patients undergoing procedures with these specific catheters may be at risk if the device malfunctions.
Check for batch numbers: 60442598, 60442599, 60448185, 60459199, 60488391, 60490138, 60451431, 60467097, 60490137, 60490168. The product has reference code H74908526511 and UDI/DI 08714729249498.
Identify if your catheter has batch numbers 60442598, 60442599, 60448185, 60459199, 60488391, 60490138, 60451431, 60467097, 60490137, or 60490168.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination in certain batches, which may cause material detachment in the inner lining and prevent guidewire advancement.
Check if your catheter has the listed batch numbers. If it does, contact Boston Scientific for further instructions.
The recall notes potential issues with guidewire advancement, but the hazard is described as a possible delamination risk rather than a direct risk of serious injury.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1674-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1674-2024 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.
