Datascope recalls specific models of Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. Affected kits include Linear 7.5Fr 34cc IAB Kit with certain lot numbers. Consumers should check their kit's product number and lot number for recall.
Potential Endotoxin Contamination
Datascope is recalling specific models of Intra-Aortic Balloon Catheters (IABs) because they may contain endotoxin contamination. This could pose a health risk during medical procedures. Affected kits have specific product numbers and lot numbers listed in the recall.
Endotoxins are bacterial components that can cause severe infections or adverse reactions when introduced into the bloodstream during medical procedures. Contaminated catheters could lead to infections or complications in patients undergoing cardiac surgery.
Healthcare professionals who use these catheters for cardiac procedures are most at risk. Patients receiving these catheters during surgery may be affected if the contaminated kit is used.
Check if your catheter kit has the product numbers 0684-00-0479-01, 0684-00-0479-01C, or 0684-00-0479-02. Look for lot numbers listed in the recall, such as 3000047635 or 3000048712.
Verify your catheter kit's product number matches the recalled models: 0684-00-0479-01, 0684-00-0479-01C, or 0684-00-0479-02.
Confirm your kit's lot number is one of the listed numbers, such as 3000047635 or 3000048712.
Endotoxins are bacterial components that can cause infections or adverse reactions when introduced into the bloodstream during medical procedures. Contaminated catheters could lead to complications in patients undergoing cardiac surgery.
Check if your kit has the product numbers 0684-00-0479-01, 0684-00-0479-01C, or 0684-00-0479-02. Also, verify your lot number matches one of the listed numbers, such as 3000047635 or 3000048712.
The recall record does not specify a remedy, so no action is required beyond checking if your kit is affected.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2839-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2839-2020 from Datascope. 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.
