OmniWire Pressure guide wire recallZ-1270-2022 · Volcano Corp · initiated May 16, 2022
Terminated
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 Corp 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
Due to a potential failed sterilization process.
FDA root cause category: Under Investigation by firm
What the company is doing
On May 16, 2022, Philips sent an "URGENT Medical Device Recall" Letter via email to Philips Sales Representatives who then delivered directly to the affected customer. The Letter informed customers that between 05/04-12/2022, potentially non-sterile products were shipped to customers. Customer are asked to immediately check their product inventory and quarantine any affected products to prevent use. Affected product is requested to be returned to Philips IGTD for replacement products. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form within 30 days upon receipt of this notice to Email: [email protected] For further information or support concerning this issue, contact the local Philips representative: Philips IGTD Customer Service: Phone: 1-800-722-9377, Option 1 Email: [email protected] Hours of Operation: Monday - Friday 8:00AM 5:00PM PST
Recall details
- Recall number
- Z-1270-2022
- Status
- Terminated
- Initiated by the company
- May 16, 2022
- Recalling firm
- Volcano Corp
- Quantity
- 11 devices
- Product code
- DXQ
- FDA submissions
- K202543
- Distribution
- U.S.: WA and WI O.U.S.: Canada
Product description
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Code information (models, lots, serial numbers)
Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OmniWire Pressure guide wire 89185JPhilips Image Guided Therapy Corporation · Wire, Guide, Catheter2 recalls31 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K202543 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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 16, 2026. Text above is shown as published by the FDA.
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