Biosense Webster recalls specific cardiac sheaths for potential minor bleeding or embolism if hemostatic valve dislodges during use. Affected models include 8.1F (medium) C3, REF: D138502, CE 2797, sold for cardiac procedures.
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 of minor bleeding or embolism if the hemostatic valve dislodges during insertion. This could affect patients undergoing cardiac electrophysiology treatments.
The hemostatic valve in the sheath might become dislodged when inserting the dilator or device. This could cause minor bleeding or embolism, which are small risks during cardiac procedures.
Patients undergoing cardiac electrophysiology procedures who use the recalled sheath. Medical professionals performing these procedures are most at risk.
Check for the model: 8.5F (medium) C3, REF: D138502, CE 2797. The sheath is sterile and used for cardiac procedures only, sold for cardiac electrophysiology mapping and ablation.
Look for the model number 8.5F (medium) C3, REF: D138502, CE 2797 on the sheath packaging or label.
The recall indicates a potential risk of minor bleeding or embolism if the hemostatic valve dislodges during insertion, so it is not recommended for use until the recall is addressed.
Contact Biosense Webster directly for assistance with the recall.
Check the model number on the sheath: 8.5F (medium) C3, REF: D138502, CE 2797. The sheath is sterile and used for cardiac procedures only.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1287-2021 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1287-2021 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.
