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EKM INFLATION DEVICE
ARGON MEDICAL DEVICES, INC. · Model 194100 · UDI-DI 00886333207619
MAV
Prescription
1
510(k) clearances
3,684
Adverse events (8 deaths)
29
Recalls
61
Facilities
Description
EKM INFLATION 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.