Maquet recalls Acrobat-i Vacuum Stabilizer Systems with risk of housing mount jaw breaking during cardiac surgery, potentially causing injury to heart tissue or blood vessels. Affected units have specific product codes and lot numbers.
Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.
Maquet is recalling its Acrobat-i Vacuum Stabilizer System used in cardiac surgery because the housing mount jaw can break during normal use. This breakage may injure heart tissue, blood vessels, or coronary arteries, or cause surgery delays.
The housing mount jaw can break during normal use, which may injure heart tissue, blood vessels, coronary arteries, or previously placed bypass grafts. This breakage could also delay or convert the surgery to a different approach.
Cardiac surgeons and surgical teams using the Maquet Acrobat-i Vacuum Stabilizer System during heart surgery are most at risk. Patients undergoing procedures with this device could be affected if the housing mount jaw breaks.
Check for product code OM-10000Z and lot numbers 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, or 3000204442 on the device. This system is intended for cardiac surgery through a sternotomy incision.
Look for product code OM-10000Z and lot numbers listed above on the device.
The housing mount jaw can break during normal use, potentially injuring heart tissue, blood vessels, coronary arteries, or bypass grafts, or causing surgery delays.
Check the product code and lot numbers on the device to see if it's affected. If it is, contact Maquet for further instructions.
Yes, the housing mount jaw breaking could injure heart tissue, blood vessels, or coronary arteries during surgery.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0137-2024 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0137-2024 from Maquet. 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.
