Boston Scientific recalls Expo 5F Selective Angiographic Catheters (model 5PKX3) after reports of guidewire not advancing properly due to polyurethane layer delamination.
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 because some batches have polyurethane layers that delaminate, causing guidewires to not advance properly. This could lead to complications during cardiac procedures if the catheter becomes stuck.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This may prevent guidewires from advancing through the catheter, potentially leading to complications during cardiac procedures if the catheter becomes stuck.
Cardiologists and cardiac catheterization teams using the recalled catheters. Patients undergoing cardiac procedures with these specific models are at risk if the catheter becomes stuck.
Check for the model number 5PKX3 on the catheter packaging or label. The batch number 60480059 is associated with this recall. The catheter has a unique identifier (UDI/DI) of 08714729249382.
Look for the model number 5PKX3 and batch number 60480059 on the catheter packaging or label.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination in certain batches, which can cause guidewires to not advance properly during cardiac procedures.
Check for the model number 5PKX3 and batch number 60480059 on the catheter packaging or label. The unique identifier (UDI/DI) is 08714729249382.
The recall record does not specify a remedy, so contact Boston Scientific directly 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-1670-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1670-2024 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.
