Z-1330-2025Class II

Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for...

Name: Z-1330-2025 Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for...
Creator: Cordis US Corp
Published: 2025-02-07
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2025-02-07 / Open, Classified / root cause: manufacturing process

FDA source

Cordis US Corp began a recall of Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of... on 2025-02-07. FDA classified it as Class II and gives the reason as "Catheter manufactured at the incorrect length". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1330-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-07
Posted: 2025-03-13
Recalling firm: Cordis US Corp.
Product: 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.
Product code: DQY Catheter, Percutaneous
Reason for recall: Catheter manufactured at the incorrect length.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 12 units
Distribution: US: WA OUS: Japan
Product codes and lots: UDI: 20705032042991/ Lot Number: 18368326

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1330-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1330-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-13

Product code DQY

K021593Class IIModification to Envoy and Vista Brite TipCordis Corp. / cleared 2002-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)