Prestige Plus 185cm J-Tip recallZ-1845-2015 · Volcano Corporation · initiated Jun 4, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Volcano Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Labeling mix-ups
What the company is doing
Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory.
Recall details
- Recall number
- Z-1845-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 4, 2015
- Posted by the FDA
- Jun 25, 2015
- Recalling firm
- Volcano Corporation
- Quantity
- 162 total (both devices)
- Product code
- DQX
- FDA submissions
- K111395
- Distribution
- US Nationwide Distribution and one account in Canada.
Product description
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.
Code information (models, lots, serial numbers)
Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.
Other devices under the same FDA submission
2 devices cleared under K111395 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PrimeWire Prestige Plus Pressure Guide Wire 185cm ST 9185Volcarica S.R.L. · Wire, Guide, Catheter1 death2 reports
- PrimeWire Prestige Plus Pressure Guide Wire 185cm JTIP 9185JVolcarica S.R.L. · Wire, Guide, Catheter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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