RenovoRx, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0565-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.

Product Classification:

Class II

Date Initiated: November 25, 2015

Date Posted: January 6, 2016

Recall Number: Z-0565-2016

Event ID: 72810

Reason for Recall:

Incorrect version of Instructions for Use were shipped to two US customers.

Status: Terminated

Product Quantity: 11 units

Code Information:

Model number: MMRC120-DB-1111; Lot number: B2456974A; Expiry 2016-07. Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.

Distribution Pattern:

US Distribution to the states of : CA and FL.

Voluntary or Mandated:

Voluntary: Firm initiated