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ECLIPSE 2L
BALT USA LLC · Model ECL2L6x15 · UDI-DI 00818053022982
1
510(k) clearances
2,330
Adverse events (101 deaths)
21
Recalls
62
Facilities
Description
ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation and deflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-12 | W. L. Gore & Associates Inc. | Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to infl |
| 2020-10-29 | Prytime Medical Devices, Inc. | There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient. |
| 2020-03-31 | Spectranetics Corporation | There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not |
| 2019-07-24 | LeMaitre Vascular, Inc. | incorrect device size being listed on the impacted device packaging |
| 2018-10-01 | LeMaitre Vascular, Inc. | Pouches from this lot are not sealed compromising the sterility |
| 2017-08-07 | Spectranetics Corporation | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. |
| 2016-10-31 | Spectranetics Corporation | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to poten |
| 2016-10-06 | AccessClosure, Inc., A Cardinal Health Company | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absen |
| 2015-11-25 | RenovoRx, Inc. | Incorrect version of Instructions for Use were shipped to two US customers. |
| 2013-11-04 | Stryker Neurovascular | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
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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.