Home › Semler Technologies, Inc. › Zephyr Vascular Compression Device
Zephyr Vascular Compression Device
Semler Technologies, Inc. · Model 9200-10 · UDI-DI 10815614020767
DXC
Prescription
1
510(k) clearances
13,076
Adverse events (78 deaths)
26
Recalls
182
Facilities
Description
The Zephyr Vascular Compression Device Model 9200-10 has two easily inflatable compression balloons, one for the radial artery and one for the ulnar artery, that are easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9200-10 provides the regular strap which is 9.8”/25cm long.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.