Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Reported: November 14, 2018 Initiated: September 5, 2018 #Z-0390-2019
Product Description
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Reason for Recall
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 162 units total (74 units in USA)
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.. Recalled by Cordis Corporation. Units affected: 162 units total (74 units in USA).
Why was this product recalled? ▼
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0390-2019.
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