Vista Brite Tip Guiding Catheter Manufactured at Incorrect Length
Cordis US Corp is recalling Vista Brite Tip guiding catheters manufactured at incorrect length. The defect may affect proper catheter placement during interventional or diagnostic vascular procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a guiding catheter used in critical coronary and peripheral vascular procedures. The manufacturing defect (incorrect length) poses a risk of improper device placement and procedure failure. No illnesses or injuries have been reported in the source material.
Plain-English summary
Cordis US Corp is recalling Vista Brite Tip, Judkins Right 4 guiding catheters (Model SM7504, Lot 18368326) because these devices were manufactured at an incorrect length. The guiding catheters are designed for intravascular introduction of interventional and diagnostic devices into coronary and peripheral vascular systems.
This manufacturing defect may affect proper catheter placement and performance during medical procedures. The recall affects 12 units that were distributed to Washington state and Japan (UDI: 20705032042991). Healthcare facilities and practitioners who have received these catheters should immediately discontinue use and review their inventory to identify any affected units from the specified lot.
The recalled product
- 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.
- Manufacturer
- Cordis US Corp
- Hazard
- incorrect-length
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 20705032042991/ Lot Number: 18368326
Distribution
Distributed in 1 state:
- WA
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