Home › Device types › MAV
Syringe, Balloon Inflation
FDA product code MAV · Class 2 · Cardiovascular
191
Registered devices
3,691
Adverse events
29
Recalls
58
510(k) clearances
Devices with this code
Insitu - ONTRAC PTCA Endoflator — ATRION MEDICAL PRODUCTS, INC.DOLPHIN — PEROUSE MEDICALDemax — Beijing Demax Medical Technology Co., Ltd.INT,Force Inflation Device — Shanghai Kindly Medical Instruments Co., Ltd.ConMed Inflation Device — ATRION MEDICAL PRODUCTS, INC.basixCOMPAK™ — Merit Medical Systems, Inc.QL Disposable Inflation Device — ATRION MEDICAL PRODUCTS, INC.AERIS Inflation Device — ATRION MEDICAL PRODUCTS, INC.Medtronic Disposable Inflation Device — ATRION MEDICAL PRODUCTS, INC.basixCOMPAK™ — Merit Medical Systems, Inc.Medex — ICU MEDICAL, INC.DiamondTOUCH™ — Merit Medical Systems, Inc.QL Disposable Inflation Device — ATRION MEDICAL PRODUCTS, INC.QL Locking Syringe Device — ATRION MEDICAL PRODUCTS, INC.basixTOUCH™ — Merit Medical Systems, Inc.CALIBER — PEROUSE MEDICALDeRoyal — DEROYAL INDUSTRIES, INC.SIS MEDICAL 55atm Inflation Device — ATRION MEDICAL PRODUCTS, INC.Demax — Beijing Demax Medical Technology Co., Ltd.basixCOMPAK™ — Merit Medical Systems, Inc.QL Disposable Inflation Device — ATRION MEDICAL PRODUCTS, INC.Medex — ICU MEDICAL, INC.Atrion QL4515 Inflation Device — ATRION MEDICAL PRODUCTS, INC.QL Disposable Inflation Device — ATRION MEDICAL PRODUCTS, 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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