Z-0390-2019 Class II Terminated
FDA device recall Z-0390-2019 was initiated by Cordis Corporation on September 5, 2018 and is designated Class II. Reason for recall: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). The recall status is terminated (terminated February 11, 2021). Affected quantity: 162 units total (74 units in USA).
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- September 5, 2018
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162 units total (74 units in USA)
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).
Distribution Pattern
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.
Code Information
Catalog Number Lot Number Expiry Date 4400322X 82144115 2020-04-30; 4400602S 82144141 2020-05-31; 4400515X 82144947 2020-06-30; 4400308S 82148810 2020-11-30; and 4400508S 82148811 2020-11-30.