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 Angiographic Catheters due to reports of polyurethane layer delamination that may prevent guidewire advancement. This could lead to complications during cardiac procedures if the catheter cannot be properly advanced through the blood vessels.
The polyurethane layer in some batches of these catheters can delaminate, causing material to detach from the inner lining. This may prevent the guidewire from advancing through the catheter, potentially leading to complications during cardiac procedures.
Cardiologists and medical professionals who use the recalled catheters during cardiac procedures are most at risk. Patients undergoing procedures with these specific catheters may experience complications if the catheter cannot be advanced properly.
Check for the model number 5F EXPO FL6 (5PK) with batch numbers 60447163, 60464498, 60485991, 60515607, 60517314, or 60533583. The catheter has a unique identifier 08714729187851.
Look for the model number 5F EXPO FL6 (5PK) with specific batch numbers listed in the recall notice.
Reach out to Boston Scientific for guidance on next steps if you have the recalled catheters.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination that may prevent guidewire advancement during cardiac procedures.
Batch numbers 60447163, 60464498, 60485991, 60515607, 60517314, and 60533583 are affected.
The recall does not require immediate discontinuation; medical professionals should check for the affected batch numbers and contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1662-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1662-2024 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.
