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NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15,...

FDA Device Recall #Z-2037-2017 — Class I — March 22, 2017

Recall Summary

Recall Number Z-2037-2017
Classification Class I — Serious risk
Date Initiated March 22, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Vascular
Location Temecula, CA
Product Type Devices
Quantity 449,661 units total (132,040 units in US)

Product Description

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

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.

Distribution Pattern

US and Worldwide

Lot / 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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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