Recall Z-2586-2025— Maquet Cardiovascular, LLC

Name: FDA recall Z-2586-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-15

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2025-08-15. It names one FDA 510(k) clearance: K130382. Product: Heartstring III Proximal Seal System. Intravascular anastomosis occluder.. Reason: 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..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-08-15
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K130382 — HEARTSTRING III PROXIMAL SEAL SYSTEMBoston Scientific Corporation·cleared 2013-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

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 adequate hemostasis.

Data sourced from openFDA. This site is unofficial and independent of the FDA.