Biosense Webster recalls specific cardiac sheaths for potential minor bleeding or embolism if the hemostatic valve dislodges during use. Affected models include 8. 5F (Large) C3, REF: D138503.
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 a specific cardiac sheath used in heart procedures due to a risk that the hemostatic valve might dislodge, causing minor bleeding or embolism. This is a serious hazard for medical professionals during procedures.
The hemostatic valve in the sheath could become dislodged when inserting the dilator or device. This might lead to minor bleeding or embolism, which are serious complications during heart procedures.
Medical professionals performing cardiac electrophysiological mapping and ablation procedures are most at risk. The recall affects all units sold globally with the specific model number.
Check for the model name 'CARTO VIZIGO', size '8.5F (Large) C3', and reference number 'D138503'. The product is sterile and used only with a prescription for cardiac procedures.
Identify the model, size, and reference number to confirm if your sheath is affected.
The recall indicates a potential risk of minor bleeding or embolism if the hemostatic valve dislodges, so it is not safe to use without checking the recall.
Look for the model 'CARTO VIZIGO', size '8.5F (Large) C3', and reference number 'D138503' on the product.
The recall does not specify a remedy, so contact Biosense Webster directly for guidance.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1286-2021 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1286-2021 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.
