Datascope recalls specific IAB catheters due to potential endotoxin contamination. Affected models include P/N 0684-00-0294-01 and variants. Consumers should check product details and contact Datascope for guidance.
Potential Endotoxin Contamination
Datascope is recalling certain intra-aortic balloon catheters (IABs) because they may contain endotoxins. This could lead to infections or other health issues if used in medical procedures. Patients using these devices should stop using them and contact Datascope for instructions.
Endotoxins are bacterial components that can cause infections when introduced into the bloodstream. In medical procedures, these contaminants could lead to serious infections, especially in vulnerable patients undergoing cardiac surgery.
Patients using the recalled Datascope IAB catheters for cardiac procedures are most at risk. Healthcare providers who have these specific models in their inventory may also be affected.
Check for product model numbers starting with 0684-00-0294-01 or variants. The kit lot numbers listed in the recall include specific sequences like 3000047044 through 3000112153. These catheters are used in cardiac procedures and may be sold through medical suppliers.
Look for the product model numbers (0684-00-0294-01, 0684-00-0294-01U, etc.) and kit lot numbers listed in the recall.
The recall is due to potential endotoxin contamination in the catheters, which could cause infections during medical procedures.
Contact Datascope directly for instructions on how to handle the recalled catheters, as the recall does not specify a return or disposal process.
Yes, these catheters are used in cardiac procedures such as acute coronary syndrome and heart failure treatments.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2831-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2831-2020 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.
