CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report
Prestige Plus J-Tip recalled by Volcano
Volcano is recalling Prestige Plus J-Tip, distributed nationwide in the US. The recall was initiated on 4 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1845-2015
- FDA event ID
- 71537
- Recalling firm
- Volcano, Rancho Cordova, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jun 2015
- FDA classified
- 25 Jun 2015
- Reported
- 1 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Jun 2015 | Recall initiated by company | |
| 25 Jun 2015 | Classified by FDA | +21 days |
| 1 Jul 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Product as listed by the FDA
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Where it was distributed
US Nationwide Distribution and one account in Canada.
Questions about this recall
Is Prestige Plus J-Tip recalled?
Yes. Volcano recalled Prestige Plus J-Tip on 4 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-1845-2015.
Why was it recalled?
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Which lots are affected?
Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.
Where was it sold?
US Nationwide Distribution and one account in Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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