Medtronic recalls specific lots of C304-HIS devices due to potential sterility compromise from improperly sealed barriers. Affected units may pose infection risks during implant procedures.
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
Medtronic is recalling certain lots of C304-HIS cardiac devices because they might have an improperly sealed barrier that could compromise sterility. This risk could lead to infections during implant procedures if the device is used without proper sterilization.
The device has a barrier that may not seal properly, potentially allowing contamination during implant procedures. This could lead to infections if the device is not sterilized correctly before use.
Patients who have received the C304-HIS device during implant procedures and healthcare providers using the device for heart procedures are most at risk. The recall affects specific lot numbers used in certain medical procedures.
Check for the model number C304-HIS on the device packaging or label. Affected lots include 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, and 0011031177.
Look for the lot numbers listed in the recall: 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, 0011031177.
The C304-HIS device is used for implant procedures involving cardiac rhythm and heart failure treatment, featuring a guide wire, valve, and deflectable catheter.
Check the lot number on the device packaging or label; affected lots include 0010948864, 0010953298, 0010958150, 0010961222, 0010971148, 0011017539, 0011020263, 0011022874, 0011025202, 0011028574, and 0011031177.
The recall does not require immediate stop use; affected devices should be checked for the specific lot numbers listed.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1206-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1206-2022 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.
