Datascope recalls specific models of Intra-Aortic Ballon Catheters (IABs) due to potential endotoxin contamination. Affected kits include P/Ns 0684-00-0480-01 and others with listed lot numbers. Consumers should check their kit details and contact Datascope for guidance.
Potential Endotoxin Contamination
Datascope is recalling certain Intra-Aortic Balloon Catheter (IAB) kits that 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.
Endotoxin contamination in medical devices can cause severe infections or adverse reactions when used in procedures. This risk is particularly concerning for critical medical applications where the device is inserted into the body.
Healthcare professionals using the recalled IAB kits for medical procedures are most at risk. Patients receiving these kits during surgery may also be affected.
Check if your kit has product numbers starting with 0684-00-0480-01 or similar, and lot numbers listed in the recall (e.g., 3000046733). The full list of affected kits and lot numbers is provided in the recall notice.
Identify your kit's product number and lot number to see if it matches the affected list provided in the recall.
The recall states there is a potential for endotoxin contamination, which could cause infections or adverse reactions during medical procedures.
Compare your kit's product number and lot number with the list of affected items provided in the recall notice.
The recall does not specify a stop-use instruction; it only lists affected kits for verification.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2840-2020 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2840-2020 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.
