FDAAugust 15, 2025device
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
maquet cardiovascularmaquet
UPCs
00607567700321
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;2026-01-09
- FDAHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System. Intravascular anastomosis occluder.2025-08-15
- FDAVasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting T...2025-08-06
- FDACorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.2025-07-14
- FDASprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.2025-06-27
- FDAServo-n Ventilator System. Model Number: 6694800.2025-05-30
- FDAServo-u Ventilator System. Model Number: 6688600.2025-05-30
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