FDA Medical devices recall ·
Heartstring III Proximal Seal System recall
- Recall number
- Z-2586-2025
- Date
- (initiated August 15, 2025)
- Company / brand
- Maquet Cardiovascular, LLC
45 Barbour Pond Dr, Wayne, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 126 units (91 US, 35 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. HS-3045; UDI: 00607567700307; Serial No. 3000365549, 3000428264, 3000447331, 3000460255, 3000365549, 3000390361, 3000420107, 3000428264, 3000447331, 3000460255, 3000475915.
Distribution
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2586-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.