Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Reported: June 22, 2016 Initiated: May 4, 2016 #Z-1947-2016
Product Description
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Reason for Recall
Inability to deploy the stent or partial stent deployment.
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 4,400 units in US; 3,100 units to Foreign Countries
- Distribution
- NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Cordis PRECISE (R) RX Nitinol Stent System (Biliary). Recalled by Cordis Corporation. Units affected: 4,400 units in US; 3,100 units to Foreign Countries.
Why was this product recalled? ▼
Inability to deploy the stent or partial stent deployment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 22, 2016. Severity: Moderate. Recall number: Z-1947-2016.
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