VISTA BRITE TIP recallZ-1330-2025 · Cordis US Corp · initiated Feb 7, 2025
Open, Classified
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 Cordis US 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
Catheter manufactured at the incorrect length.
FDA root cause category: Employee error
What the company is doing
On February 7, 2025 Cordis issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. Cordis asked consignees to take the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory for any units from the affected lot in your possession. 3. Identify and quarantine any units. Check all storage and usage locations. 3) Share this letter with others in your facility who need to be made aware of this recall and with any other facility. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: [email protected] 5) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product.
Recall details
- Recall number
- Z-1330-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 7, 2025
- Posted by the FDA
- Mar 13, 2025
- Recalling firm
- Cordis US Corp
- Quantity
- 12 units
- Product code
- DQY
- FDA submissions
- K021593
- Distribution
- US: WA OUS: Japan
Product description
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Code information (models, lots, serial numbers)
UDI: 20705032042991/ Lot Number: 18368326
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VISTA BRITE TIP SM7504Cordis Corporation · CATHETER, PERCUTANEOUS1 recall0 reports
Product lines
Other devices under the same FDA submission
9 devices cleared under K021593 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CORDIS 67000400Cordis US Corp. · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- CORDIS 67000200Cordis US Corp. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- VISTA BRITE TIP 670-052-00MCordis US Corp. · Catheter, percutaneous3 reports
- VISTA BRITE TIP 6700540ECordis Corporation · CATHETER, PERCUTANEOUS2 reports
- VISTA BRITE TIP 6700820ECordis Corporation · CATHETER, PERCUTANEOUS2 reports
- CORDIS 67000000Cordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- CORDIS 67000300Cordis US Corp. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- VISTA BRITE TIP 6700820LCordis Corporation · CATHETER, PERCUTANEOUS1 report
- BRITE TIP 55608200Cordis US Corp. · CATHETER, PERCUTANEOUS1 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 16, 2026. Text above is shown as published by the FDA.
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