Reported Sep 3, 2014 · Terminated
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- Cordis EMPIRA NC RX PTCA Dilatation Catheter
- Lot codes and dates
- 63
- Catalog numbers
63 of 63 codes
75R06200N75R06225N75R06250N75R06275N75R06300N75R06325N75R06350N75R06375N75R06400N75R10200N75R10225N75R10250N75R10275N75R10300N75R10325N75R10350N75R10375N75R10400N75R12200N75R12225N75R12250N75R12275N75R12300N75R12325N75R12350N75R12375N75R12400N75R15200N75R15225N75R15250N75R15275N75R15300N75R15325N75R15350N75R15375N75R15400N75R20200N75R20225N75R20250N75R20275N75R20300N75R20325N75R20350N75R20375N75R20400N75R25200N75R25225N75R25250N75R25275N75R25300N75R25325N75R25350N75R25375N75R25400N75R25200N75R25225N75R25250N75R25275N75R25300N75R25325N
- Amount recalled
- 250,000 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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