Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Maquet Cardiovascular, LLC
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Product Codes/Lot Numbers:
UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0137-2024
Related Recalls
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Maquet Cardiovascular
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Maquet Cardiovascular
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.