Z-0712-2025 Class I Ongoing
FDA device recall Z-0712-2025 was initiated by Maquet Cardiovascular, LLC on December 9, 2024 and is designated Class I. Reason for recall: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool The recall status is ongoing. Affected quantity: 11,101 units US.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- December 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,101 units US
Product Description
Reason for Recall
Distribution Pattern
Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.