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Indeflator
ABBOTT VASCULAR INC. · Model 1000185 · UDI-DI 08717648013607
MAV
Prescription
10
510(k) clearances
3,682
Adverse events (8 deaths)
29
Recalls
61
Facilities
Description
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
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 investigation determine |
| 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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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.