Cordis EMPIRA NC RX PTCA Dilatation Catheter
Reported: September 3, 2014 Initiated: June 23, 2014 #Z-2556-2014
Product Description
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Reason for Recall
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 250,000 units
- Distribution
- Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Cordis EMPIRA NC RX PTCA Dilatation Catheter. Recalled by Cordis Corporation. Units affected: 250,000 units.
Why was this product recalled? ▼
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2014. Severity: Moderate. Recall number: Z-2556-2014.
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