RenovoCath
Renovorx, Inc. · Model 009003 rev 4 · UDI-DI 00851994005003
Description
The RenovoCath is a multi-lumen, dual-balloon catheter having a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The inflation of the proximal occlusion balloon and of the distal occlusion balloon may isolate the selected site prior to the infusion of fluids into the same site. The two balloons are inflated independently using diagnostic contrast agents delivered via two separate inflation lumens. The distance between the proximal occlusion balloon and the distal occlusion balloon is controlled by the operator. Radiopaque markers are located between the two balloons to allow for identification of target site and position adjustment under fluoroscopic guidance. The RenovoCath is supplied sterile, is for single use and is disposable.
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 abse |
| 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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