Biosense Webster recalls specific cardiac sheaths due to potential hemostatic valve dislodgement during use, risking minor bleeding or embolism. Affected units include 8.5F (SMALL) C3 models with REF D138501.
There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
Biosense Webster is recalling certain cardiac sheaths that could dislodge a hemostatic valve during medical procedures, potentially causing minor bleeding or embolism. This is a safety issue for doctors using these devices in heart treatments.
The hemostatic valve inside the sheath could become dislodged when inserting the device, leading to minor bleeding or embolism. This risk occurs during standard medical procedures for heart mapping and ablation.
Doctors and medical professionals who use the recalled sheaths for cardiac procedures are most at risk. Patients receiving these procedures may also be affected if the sheath is used incorrectly.
Check for the model number 8.5F (SMALL) C3 with reference number D138501. The product is labeled as 'Rx Only' and sold with CE 2797 certification.
Verify the model number and reference code on the sheath to confirm if it matches the recalled version.
Reach out to Biosense Webster directly for guidance on next steps if you have the recalled sheath.
The recall indicates a potential risk during use, but the product is generally safe if handled properly. Consult the manufacturer for specific guidance.
The official recall does not specify a remedy, so contact Biosense Webster directly for instructions.
Look for the model number 8.5F (SMALL) C3 with reference code D138501 on the sheath label.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1285-2021 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1285-2021 from Biosense Webster. 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.
