Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 6, 2016
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.
Incorrect version of Instructions for Use were shipped to two US customers.
RenovoRx, Inc. recalled RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-… - a moderate-severity action.
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-… was recalled by RenovoRx, Inc. in January 6, 2016. Reason: Incorrect version of Instructions for Use were shipped to two US customers.. Check the official notice for the remedy. Verify recall #Z-0565-2016 with the FDA Devices before acting.
The recall
RenovoRx, Inc. issued this moderate-severity FDA Devices recall-Incorrect version of Instructions for Use were shipped to two US customers..
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- January 6, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0565-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0565-2016) was formally reported on January 6, 2016, with the manufacturer initiating the action on November 25, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. RenovoRx, Inc. is listed as the recalling firm, operating out of Los Altos, CA. Federal records list the affected scope as 11 units.
The documented reason for this recall is: Incorrect version of Instructions for Use were shipped to two US customers. Distribution data in the federal record shows the product reached: US Distribution to the states of : CA and FL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11 units
Related Recalls
6
3 from same agency
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.
Reason for recall
Incorrect version of Instructions for Use were shipped to two US customers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0565-2016 |
| Date reported | January 6, 2016 |
| Date initiated | November 25, 2015 |
| Recalling firm | RenovoRx, Inc. |
| Firm location | Los Altos, CA |
| Affected scope | 11 units |
| Distribution | US Distribution to the states of : CA and FL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0565-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by RenovoRx, Inc.. Units affected: 11 units.
Why was this product recalled? ▼
Incorrect version of Instructions for Use were shipped to two US customers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2016. Severity: Moderate. Recall number: Z-0565-2016.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : CA and FL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0565-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 6, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.