Medtronic recalls Cardioblate CryoFlex surgical ablation probes with potential defective sterile pouch seals. This could lead to contamination during medical procedures. Affected models include 60SF7 with specific serial numbers.
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 lead to contamination during medical procedures if the pouch fails to maintain sterility.
The sterile barrier pouch that packages the probe may have a defect in its seals. If the pouch fails to maintain sterility, it could lead to contamination during medical procedures. This poses a risk of infection or other complications for patients.
Healthcare professionals using the Cardioblate CryoFlex probes for surgical ablation procedures are most at risk. Patients undergoing these procedures may be affected if the probe becomes contaminated.
Check for the model number 60SF7 on the probe. Look for serial numbers starting with 17720000 through 17720021 or 20620000. The product is a single-use disposable cryoprobe for surgical ablation.
Identify the model number (60SF7) and serial numbers (17720000-17720021 or 20620000) on the probe.
The recall is due to a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices.
If the pouch seals are defective, it could lead to contamination during medical procedures, potentially causing infection or other complications.
Check for model number 60SF7 and serial numbers starting with 17720000 through 17720021 or 20620000.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0495-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0495-2021 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.
