Recall Z-2318-2015— Cook Inc.
Class I · Terminated
Class I FDA medical device recall by Cook Inc., initiated 2015-07-02, terminated 2017-09-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.. Reason: Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result..
- Recalling firm
- Cook Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-07-02
- Terminated
- 2017-09-02
- Firm location
- Bloomington, IN, United States
Product description
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
Reason for recall
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
Data sourced from openFDA. This site is unofficial and independent of the FDA.