Medtronic recalls Cardioblate CryoFlex surgical ablation probes with model 60SF3 due to potential seal defects in sterile packaging that could compromise sterility during use.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Medtronic is recalling specific Cardioblate CryoFlex surgical ablation probes (model 60SF3) because the sterile packaging may have defective seals. This could lead to contamination during medical procedures if the probe is used without proper sterility.
The sterile barrier pouch packaging for these probes may have defective seals. If the pouch fails during use, it could allow contaminants to enter the probe, compromising sterility during surgical procedures.
Surgical teams using the recalled Cardioblate CryoFlex probes for ablation procedures are affected. Patients undergoing these procedures with the recalled probes face a potential risk of contamination.
Check for model number 60SF3 on the probe. The serial numbers listed in the recall include specific ranges from 17420000 to 22320044. The product is a single-use disposable cryoprobe for surgical ablation systems.
Look for the serial numbers listed in the recall (17420000 to 22320044) on the probe packaging or device.
Reach out to Medtronic directly for further instructions or to confirm if your specific probe is affected.
The recall indicates a potential seal defect in the sterile packaging, so it is not recommended for use until the issue is resolved.
Check the serial number against the list provided in the recall and contact Medtronic for further instructions.
The affected probes have model number 60SF3 with serial numbers from 17420000 to 22320044 as listed in the recall.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0494-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0494-2021 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.
