Home › SYNOVIS LIFE TECHNOLOGIES, INC. › Flo-Rester® Disposable Internal Vessel Occluder
Flo-Rester® Disposable Internal Vessel Occluder
SYNOVIS LIFE TECHNOLOGIES, INC. · Model 50100 · UDI-DI 00085412531908
DXC
Prescription
1
510(k) clearances
12,981
Adverse events (78 deaths)
26
Recalls
182
Facilities
Description
Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a T configuration. Flo-Rester bulbs and tab are radiopaque.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-15 | Maquet Cardiovascular, LLC | 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 Heartst |
| 2025-08-15 | Maquet Cardiovascular, LLC | 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 Heartst |
| 2025-08-15 | Maquet Cardiovascular, LLC | 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 Heartst |
| 2025-07-01 | North American Rescue LLC. | Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device a |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2022-04-01 | Baxter Healthcare Corporation | There is a potential for foreign matter. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.