Abbott recalls specific models of cardiac catheters due to reported air embolism risks during procedures. Affected units have unique batch numbers and UDI/DI codes.
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Abbott is recalling certain cardiac catheters (ASDS-14F-075) because they have been linked to air embolism incidents during medical procedures. This risk could potentially cause serious complications for patients undergoing cardiac treatments.
The catheter has been associated with a reported 0.77% incidence rate of air embolism during procedures. Air embolism occurs when air enters the bloodstream, which can cause serious complications like stroke or cardiac arrest.
Patients undergoing cardiac procedures using the recalled catheter model are most at risk. Healthcare providers using the specific batch numbers listed in the recall are also affected.
Check for the product code ASDS-14F-075 and batch numbers listed: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835. The unique device identifier (UDI/DI) is 05415067036025.
Identify if your catheter matches the product code ASDS-14F-075 and the listed batch numbers.
The recall reports a 0.77% incidence rate of air embolism during procedures, which is a potential risk but not guaranteed to cause harm.
Check for the product code ASDS-14F-075 and batch numbers listed: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835.
The recall does not specify a remedy, so contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2110-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2110-2023 from Abbott. 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.