Boston Scientific recalls Expo 5F Selective Angiographic Catheters with polyurethane layer delamination risk. Affected units have specific batch numbers; contact for remedy.
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 the polyurethane layer delaminating and causing guidewire blockage. This could prevent proper catheter advancement during medical procedures.
The catheters' polyurethane layer may detach, creating a blockage that prevents guidewires from advancing through the device. This can cause delays or failures during critical cardiac procedures.
Cardiologists and medical professionals using the recalled catheters for cardiac procedures. Patients undergoing these procedures with affected catheters are at risk of complications.
Check for batch numbers: 60437054, 60447182, 60463964, 60477273, 60488498, 60495556, and other listed numbers. The product is a 5F EXPO WR (5PK) catheter with UDI/DI 08714729249412.
Look for batch numbers on the catheter packaging or label: 60437054, 60447182, 60463964, 60477273, 60488498, 60495556, and other listed numbers.
Reach out to Boston Scientific for instructions on whether the catheter is affected and what to do next.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing guidewire blockage during cardiac procedures.
Affected batch numbers include 60437054, 60447182, 60463964, 60477273, 60488498, 60495556, and other specific numbers listed in the recall.
No immediate stop is required; medical professionals should check 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-1672-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1672-2024 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.
