Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential polyurethane layer delamination causing guidewire advancement issues. Affected units include specific batch numbers and model.
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 Angi:ograpic Catheters due to reports of polyurethane layer delamination that may prevent guidewire advancement. This could lead to complications during cardiac procedures if the catheter fails to function properly.
The polyurethane layer in some batches may delaminate, causing material detachment in the catheter's inner lining. This can prevent guidewires from advancing through the device, potentially leading to procedural complications during cardiac catheterization.
Cardiovascular specialists and hospitals using the recalled catheters are most at risk. Patients undergoing cardiac procedures with these specific models may experience complications if the catheter malfunctions.
Check for the model number 5F EXPO MULTIPACK 145 (SGL), reference number H749085263011, and batch numbers 60451436, 60470651, 60490172, or 60495478. The catheter has a unique identifier UDI/DI 08714729521518.
Identify the model number, reference number, and batch numbers listed in the recall notice to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing material detachment in the inner lining, which may prevent guidewire advancement during procedures.
Check the model number, reference number, and batch numbers to see if your catheter is affected. If it is, contact Boston Scientific for further instructions.
Yes, if the catheter malfunctions during cardiac procedures, it could lead to complications such as inability to advance guidewires, potentially causing procedural issues.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1667-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1667-2024 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.
