Reported Feb 26, 2020 · Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary…
Abbott Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary
- Dilatation Catheter is indicated fora) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)
- Lot codes and dates
- Device Identifier/GTIN08717648152146
- Part Number1012455-12
- Lot Numbers90918G1 90930G1 90926G1 91031G1
- Amount recalled
- Total 39687 NC TREK units (13891 US and 25796 OUS)
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Why it was recalled
Stop using this product now
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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