Reported Sep 3, 2014 · Terminated
Cordis EMPIRA 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 RX PTCA Dilatation Catheter
- Lot codes and dates
- 70
- Catalog numbers
69 of 69 codes
85R06150S85R06200S85R06225S85R06250S85R06275S85R06300S85R06325S85R06350S85R06375S85R06400S85R10150S85R10200S85R10225S85R10250S85R10275S85R10300S85R10325S85R10350S85R10375S85R10400S85R12150S85R12200S85R12225S85R12250S85R12275S85R12300S85R12325S85R12350S85R12375S85R12400S85R15150S85R15200S85R15225S85R15250S85R15275S85R15300S85R15325S85R15350S85R15375S85R15400S85R20150S85R20200S85R20225S85R20250S85R20275S85R20300S85R20325S85R20350S85R20375S85R20400S85R25150S85R25200S85R25225S85R25250S85R25275S85R25300S85R25325S85R25350S85R25375S85R25400S
- 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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