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Echelon
Micro Therapeutics, Inc. · Model 105-5092-150 · UDI-DI 00836462002258
KRA
Prescription
1
510(k) clearances
8,965
Adverse events (358 deaths)
96
Recalls
148
Facilities
Description
14 Micro Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-18 | Angiodynamics, Inc. | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
| 2023-11-06 | Merit Medical Systems, Inc. | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2020-11-03 | Boston Scientific Corporation | This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2017-11-09 | Vascular Insights, LLC | Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction |
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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.