Home › Device types › MAV
Syringe, Balloon Inflation
FDA product code MAV · Class 2 · Cardiovascular
190
Registered devices
3,682
Adverse events
29
Recalls
57
510(k) clearances
Devices with this code
Blue Diamond™ — Merit Medical Systems, Inc.Fluent™ inflation device — Vascular Solutions, Inc.QL Disposable Inflation Device — ATRION MEDICAL PRODUCTS, INC.QL Locking Syringe Device — ATRION MEDICAL PRODUCTS, INC.basixCOMPAK™ — Merit Medical Systems, Inc.QL Locking Syringe Device — ATRION MEDICAL PRODUCTS, INC.DiamondTOUCH™ — Merit Medical Systems, Inc.basixTOUCH™ — Merit Medical Systems, Inc.EVEREST™ — MEDTRONIC, INC.basixCOMPAK™ — Merit Medical Systems, Inc.Demax — Beijing Demax Medical Technology Co., Ltd.SwitchBack™ — B BRAUN INTERVENTIONAL SYSTEMS, INCDiamondTOUCH™ — Merit Medical Systems, Inc.basixCOMPAK™ — Merit Medical Systems, Inc.DOLPHIN — PEROUSE MEDICALbasixTOUCH™ — Merit Medical Systems, Inc.Medex — ICU MEDICAL, INC.Encore 40 Inflation Device — ATRION MEDICAL PRODUCTS, INC.Demax — Beijing Demax Medical Technology Co., Ltd.Stryker AVA/iVAS® Inflator — ATRION MEDICAL PRODUCTS, INC.DiamondTOUCH™ — Merit Medical Systems, Inc.basixCOMPAK™ — Merit Medical Systems, Inc.EVEREST™ — MEDTRONIC, INC.basixCOMPAK™ — Merit Medical Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-05 | Boston Scientific Corporation | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal inv |
| 2024-11-06 | Abbott Vascular Inc | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. |
| 2024-11-06 | Abbott Vascular Inc | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. |
| 2024-11-06 | Abbott Vascular Inc | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. |
| 2024-11-06 | Abbott Vascular Inc | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. |
| 2022-03-11 | Abbott Vascular | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
| 2022-03-11 | Abbott Vascular | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
| 2022-03-11 | Abbott Vascular | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
| 2022-03-11 | Abbott Vascular | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
| 2022-03-11 | Abbott Vascular | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
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