Indeflator
PLUS 30 PRIORITY PACK Accessory Kit includes INDEFLATOR PLUS 30 Inflation Device 30 atm 10 cc / Rotating Hemostatic Valve .096 " / Guide Wire Introducer / Torque Device
6manufacturers in China registered for this device type
6catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Abbott Vascular, United States |
|---|---|
| FDA product code | MAV |
| Device type | Syringe, Balloon Inflation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-08-05 |
| Record revised | 2024-08-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dry, dark, cool place. |
| Distribution end date | 2023-01-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1000186-115 | In distribution | |
| 1000184 | In distribution | |
| 1000186 | In distribution | |
| 1000185-115 | Withdrawn | |
| 1000183 | Withdrawn | |
| 1000185 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 18 |
| Everest™ | Medtronic, Inc. | 16 |
| basixCOMPAK™ | Merit Medical Systems, Inc. | 16 |
| QL Disposable Inflation Device | Atrion Medical Products, Inc. | 15 |
| basixTOUCH™ | Merit Medical Systems, Inc. | 12 |
| Fluent™ inflation device | Vascular Solutions LLC | 10 |
| DeRoyal | Deroyal Industries, Inc. | 4 |
| QL Locking Syringe Device | Atrion Medical Products, Inc. | 4 |
| QL® Inflation Device | Atrion Medical Products, Inc. | 4 |
| Sphere™ Inflation Device | Atrion Medical Products, Inc. | 3 |
| Medex | ICU Medical, Inc | 3 |
| DiamondTOUCH™ | Merit Medical Systems, Inc. | 3 |
Showing 12 of 39. All products under Syringe, Balloon Inflation
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Vascular | UDI-DI | 2024-11-06 | Class II | Component change control | 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. | 1,418 |
| Abbott Vascular | UDI-DI | 2024-11-06 | Class II | Component change control | 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. | 3,673 |
| Abbott Vascular | UDI-DI | 2024-11-06 | Class II | Component change control | 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. | 4,975 |
| Abbott Vascular | UDI-DI | 2022-03-11 | Class II | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. | 17 lots |
| Abbott Vascular | UDI-DI | 2022-03-11 | Class II | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. | 23 lots |
| Abbott Vascular | UDI-DI | 2022-03-11 | Class II | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. | 6 lots |
| Abbott Vascular | UDI-DI | 2022-03-11 | Class II | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. | 7 lots |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-11-06 | Class II | Component change control | 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. | 23,407 |
| 2022-03-11 | Class II | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. | 131 lots |
| 2018-07-03 | Class II | Incorrect or no expiration date | Incorrect expiration being entered for one lot. | 26 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.