Medtronic recalls Cardioblate CryoFlex surgical ablation probes with potential defective sterile pouch seals that could compromise sterility during use. Affected models include 60CM1, GTIN 00763000114640, serial numbers 18920000-18920002.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Medtronic is recalling Cardioblate CryoFlex surgical ablation probes due to a potential defect in the sterile barrier pouch seals. This could compromise sterility during medical procedures, posing a risk of infection to patients.
The sterile barrier pouch seals may be defective, potentially allowing contamination during medical procedures. This could lead to infections if the probes are not properly sterilized before use.
Surgical teams using the Cardioblate CryoFlex probes for ablation procedures are most at risk. Patients receiving these procedures may face infection risks if the probes are used without proper sterility.
Check for model number 60CM1, GTIN 00763000114640, or serial numbers 18920000-18920002 on the probe packaging. These are single-use disposable cryoprobe devices for surgical ablation procedures.
Verify the model number, GTIN, and serial numbers on the probe packaging to confirm if it's affected.
The recall is due to a potential defect in the sterile barrier pouch seals that could compromise sterility during medical procedures.
Using the probe without proper sterility could lead to infections in patients during surgical procedures.
Check for model number 60CM1, GTIN 00763000114640, or serial numbers 18920000-18920002 on the probe packaging.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0496-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0496-2021 from Medtronic. 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.
