Medtronic recalls Cardioblate CryoFlex surgical ablation probes with defective sterile pouch seals that could compromise sterility during procedures.
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 with model number 60SF2 that have potentially defective sterile pouch seals. This could lead to contamination or infection risks during medical procedures if the seal fails.
The sterile barrier pouch used to package the probes may have a defect that allows contamination. If the seal fails during use, it could compromise the sterility of the probe and increase infection risks during surgery.
Surgical teams using the Cardioblate CryoFlex probes for ablation procedures are most at risk. Patients undergoing these procedures could face infection risks if the defective seal compromises sterility.
Check for model number 60SF2, serial numbers starting with 18920030-18920055 or 20420030-20420051. These probes were sold with the CryoFlex Surgical Ablation System for surgical ablation procedures.
Verify the model number and serial numbers listed in the recall notice to confirm if your probe is affected.
The sterile barrier pouch used to package the probes has a potential defect that could compromise sterility during use.
Check for model number 60SF2 and serial numbers starting with 18920030-18920055 or 20420030-20420051 as listed in the recall notice.
The recall notice does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0493-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0493-2021 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.
