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U.S. Department of Health and Human Services

Class 1 Device Recall NC Trek RX Coronary Dilatation Catheter

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  Class 1 Device Recall NC Trek RX Coronary Dilatation Catheter see related information
Date Initiated by Firm March 22, 2017
Create Date May 12, 2017
Recall Status1 Open3, Classified
Recall Number Z-2037-2017
Recall Event ID 76841
510(K)Number K103153  
Product Classification Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
Product NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25, 1012452-08, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20




















Code Information Lot Number, 60414G1, 60721G1, 60208G1, 60419G1, 60420G1, 60603G1, 60906G1, 61121G1, 61121G2, 60225G1, 60229G1, 60318G1, 60318G2, 60429G1, 60429G2, 60607G1, 60705G1, 60804G1, 60818G1, 60921G1, 60921G2, 61108G1, 61111G1, 61128G1, 61128G2, 61218G1, 60202G1, 60310G1, 60401G1, 60408G1, 60408G2, 60510G1, 60616G1, 60721G1, 60809G1, 60912G1, 61014G1, 61028G1, 61206G1, 61206G2, 60310G1, 60421G1, 60421G2, 60527G1, 60716G1, 60819G1, 61024G2, 60523G1, 61026G1, 60317G1, 60318G1, 60412G1, 60419G1, 60502G1, 60502G2, 60525G1, 60705G1, 60801G1, 60809G1, 60826G1, 60916G1, 61018G1, 61121G1, 61121G2, 60218G1, 60303G1, 60330G1, 60330G2, 60406G1, 60406G2, 60406G3, 60406G4, 60408G1, 60413G1, 60413G2, 60425G1, 60429G1, 60511G1, 60512G1, 60531G1, 60607G1, 60623G1, 60713G1, 60721G1, 60804G1, 60805G1, 60809G1, 60812G1, 60816G1, 60824G1, 60926G1, 60929G1, 61012G1, 61019G1, 61019G2, 61020G1, 61115G1, 61121G1, 61122G1, 61123G1, 61123G2, 61201G1, 61208G1, 61214G1, 61214G2, 61216G1, 61216G2, 60128G1, 60215G1, 60215G2, 60224G1, 60322G1, 60329G1, 60330G1, 60330G2, 60330G3, 60401G1, 60407G1, 60407G2, 60427G1, 60428G1, 60428G2, 60428G3, 60429G1, 60502G1, 60603G1, 60609G1, 60621G1, 60718G1, 60720G1, 60727G1, 60801G1, 60809G1, 60810G1, 60816G1, 60824G1, 60906G1, 60919G1, 60926G1, 60928G1, 61104G1, 61107G1, 61111G1, 61111G3, 61122G1, 61123G1, 61128G1, 61130G1, 61202G1, 60126G1, 60223G1, 60225G1, 60226G1, 60323G1, 60331G1, 60331G2, 60516G1, 60519G1, 60721G1, 60805G1, 60824G1, 60907G1, 61004G1, 61116G1, 61128G1, 61130G1, 61206G1, 60405G1, 60412G1, 60805G1, 60610G1, 61101G1, 60530G1, 60803G1, 61014G1, 61206G1, 60212G1, 60412G1, 60414G1, 60528G1, 60623G1, 60831G1, 60921G1, 61104G1, 61207G1, 61209G1, 60315G1, 60317G1, 60328G1, 60414G1, 60414G2, 60613G1, 60718G1, 60810G1, 60901G1, 60922G1, 61128G1, 61130G1, 60318G1, 60329G1, 60429G1, 60613G1, 60804G1, 60929G1, 60603G1, 61006G1, 60323G1, 60329G1, 60329G2, 60330G1, 60425G1, 60428G1, 60526G1, 60531G1, 60623G1, 60713G1, 60805G1, 60819G1, 60929G1, 61104G1, 61204G1, 61206G1, 61207G1, 61208G1, 60205G1, 60214G1, 60215G1, 60322G1, 60330G1, 60408G1, 60415G2, 60415G3, 60415G4, 60418G1, 60418G2, 60502G1, 60525G2, 60527G1, 60527G2, 60601G1, 60616G1, 60629G1, 60720G1, 60729G1, 60805G1, 60818G1, 60829G1, 60907G1, 60922G1, 61003G1, 61010G1, 61107G1, 61108G1, 61114G1, 61122G1, 61123G1, 61130G1, 61212G1, 61212G2, 61213G1, 60210G1, 60224G1, 60226G1, 60227G1, 60229G1, 60307G1, 60314G1, 60329G1, 60329G2, 60331G1, 60401G1, 60408G1, 60408G2, 60505G1, 60512G1, 60603G1, 60607G1, 60628G1, 60701G1, 60720G1, 60727G1, 60801G1, 60818G1, 60826G1, 60826G2, 60909G1, 60909G2, 60913G1, 60920G1, 61010G1, 61024G1, 61101G1, 61115G1, 61118G1, 61123G1, 61123G2, 61202G1, 61204G1, 61214G1, 60128G1, 60307G1, 60310G1, 60318G1, 60329G1, 60419G1, 60419G2, 60519G1, 60603G1, 60824G1, 60830G1, 60901G1, 60927G1, 61115G1, 61121G1, 61201G1, 60809G1, 50114G1, 50316G1, 50319G1, 50513G1, 51022G1, 51217G1, 60112G1, 60603G1, 60810G1, 60921G1, 61007G1, 61216G1, 50109G1, 50210G1, 50306G1, 50317G1, 50330G1, 50420G1, 50817G1, 50928G1, 51023G1, 51029G1, 60217G1, 60226G1, 60308G1, 60311G1, 60712G1, 60909G1, 61102G1, 61122G1, 50105G1, 50115G1, 50213G1, 50316G1, 50319G1, 50420G1, 50609G1, 50929G1, 51103G1, 51109G1, 60224G1, 60331G1, 60405G1, 60505G1, 60718G1, 60726G1, 60826G1, 61115G1, 61128G1, 61208G1, 50106G1, 50120G1, 50204G1, 50206G1, 50316G1, 50603G1, 51110G1, 60412G1, 60607G1, 61018G1, 60405G1, 60413G1, 60413G2, 60425G1, 60425G2, 60621G1, 60720G1, 60729G1, 60819G1, 61026G1, 61130G1, 61204G1, 60302G1, 60408G1, 60415G1, 60502G1, 60502G2, 60503G1, 60503G2, 60621G1, 60705G1, 60722G1, 60810G1, 60907G1, 61004G1, 61012G1, 61214G1, 61218G1, 60301G1, 60303G1, 60329G1, 60331G1, 60427G1, 60428G1, 60613G1, 60617G1, 60721G1, 60819G1, 60822G1, 60909G1, 61026G1, 61111G1, 61121G1, 60209G1, 60226G1, 60505G1, 60623G1, 60810G1, 60926G1, 61122G1.
Recalling Firm/
Manufacturer
Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer Reason
for Recall
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
FDA Determined
Cause 2
Device Design
Action An Urgent Field Safety Notice dated 3/22/17 was sent to customers to inform them that Abbott Vascular is recalling the NC Trek RX Coronary Dilation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PCTA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The letter informs the customers of how does the issue occur and what action is Abbott Vascular asking the customers to take. Customers with any questions are instructed to contact local Abbott Vascular Representative or Customer Service Department at (800) 227-9902.
Quantity in Commerce 449,661 units total (132,040 units in US)
Distribution US and Worldwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LOX and Original Applicant = ABBOTT VASCULAR-CARDIAC THERAPIES
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