Datascope recalls specific models of Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. Affected kits include P/Ns 0684-00-0296-01 and others. Consumers should check their kit lot numbers for affected units.
Potential Endotoxin Contamination
Datascope is recalling certain Intra-Aortic Balloon Catheter (IAB) kits due to potential endotoxin contamination. This could pose a risk to patients during medical procedures, especially in critical care settings.
Endotoxins are bacterial components that can cause severe infections or septic shock when introduced into the bloodstream. The potential contamination in these specific IAB kits could lead to serious health complications during medical procedures.
Healthcare professionals using the recalled IAB kits for cardiac and non-cardiac surgery, heart failure complications, or acute coronary syndrome procedures are most at risk. Patients receiving these kits during medical treatment may be affected.
Check your IAB kit's product number (P/N) for 0684-00-0296-01, 0684-00-0296-01U, 0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10, 0684-00-0498-01, 0684-00-0498-07, or 0684-00-0498-08. Also check the kit lot numbers listed in the recall notice for affected units.
Review your IAB kit's lot numbers to determine if they are listed in the affected list (e.g., 3000046414, 3000047431, etc.).
The recall states potential endotoxin contamination, which could lead to serious infections or septic shock during medical procedures.
Check your kit's product number (P/N) and lot number against the list provided in the recall notice.
If your kit's lot number is not listed, it is not affected by this recall and no action is required.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2833-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2833-2020 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.
