Z-2586-2025 Class II Ongoing
FDA device recall Z-2586-2025 was initiated by Maquet Cardiovascular, LLC on August 15, 2025 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 126 units (91 US, 35 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2025
- Initiation Date
- August 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126 units (91 US, 35 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.