Datascope recalls specific 7.5Fr 40cc IAB kits (P/Ns 0684-00-0295-01 to 0684-00-0295-10) due to potential endotoxin contamination. Affected kits include certain lot numbers for cardiac and heart failure procedures.
Potential Endotoxin Contamination
Datascope is recalling specific intra-aortic balloon catheter kits (IABs) that may contain endotoxin contamination. This could pose a risk during cardiac procedures like heart failure treatment or acute coronary syndrome. Affected kits have specific product numbers and lot numbers listed in the recall.
Endotoxins are bacterial components that can cause severe infections when introduced into the bloodstream. In cardiac procedures, contaminated kits could lead to life-threatening sepsis or other serious complications if the endotoxin enters the patient's body.
Healthcare professionals using these IAB kits for cardiac procedures like heart failure treatment or acute coronary syndrome are most at risk. Patients undergoing such procedures with the recalled kits could be affected.
Check for product numbers starting with 0684-00-0295-01 through 0684-00-0295-10. Affected kits include specific lot numbers listed in the recall notice for cardiac and heart failure procedures.
Identify kits with product numbers starting with 0684-00-0295-01 through 0684-00-0295-10.
The recall is due to potential endotoxin contamination in specific IAB kits, which could cause serious infections during cardiac procedures.
These kits are used for acute coronary syndrome, cardiac surgery, and complications of heart failure.
Check the product number on the kit; affected kits have specific numbers listed in the recall (0684-00-0295-01 to 0684-00-0295-10).
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2832-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2832-2020 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.
