CLASS I Device recall · Reported 24 May 2017 · FDA Enforcement Report

NC Tenku RX PTCA Balloon Catheter recalled by Abbott Vascular

Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheter. The recall was initiated on 22 Mar 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Number 60202G1 60301G1 60502G1 60301G1 60401G1 61101G1 60202G1 60401G1 60601G1 60801G1 61101G1 60302G1 60401G1 60601G1 60801G1 60202G1 60401G1 60502G1 60601G1 60701G1 60902G1 61004G1 61101G1 60202G1 60301G1 60401G1 60502G1 60601G1 60701G1 60801G1 60902G1 61101G1 60401G1 60601G1 60801G1 60301G1 60701G1 60301G1 60502G1 60701G1 60301G1 60502G1 60701G1 60902G1 60301G1 60502G1 60701G1 61004G1 60301G1 60401G1 60601G1 60701G1 60805G1 61004G1 50204G1 50406G1 50202G1 50901G1 50204G1 60202G1 60502G1 60701G1 61101G1 60202G1 60506G1

Quantity recalled449,661 units total (132,040 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2039-2017
FDA event ID: 76841
Recalling firm: Abbott Vascular, Temecula, CA
Classification: Class I
Status: Terminated
Recall initiated: 22 Mar 2017
FDA classified: 12 May 2017
Reported: 24 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

22 Mar 2017	Recall initiated by company
12 May 2017	Classified by FDA	+51 days
24 May 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T

Where it was distributed

US and Worldwide

Questions about this recall

Is NC Tenku RX PTCA Balloon Catheter recalled?

Yes. Abbott Vascular recalled NC Tenku RX PTCA Balloon Catheter on 22 Mar 2017. The recall is Class I and its status is Terminated. Recall number Z-2039-2017.

Why was it recalled?

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.

Which lots are affected?

Lot Number 60202G1 60301G1 60502G1 60301G1 60401G1 61101G1 60202G1 60401G1 60601G1 60801G1 61101G1 60302G1 60401G1 60601G1 60801G1 60202G1 60401G1 60502G1 60601G1 60701G1 60902G1 61004G1 61101G1 60202G1 60301G1 60401G1 60502G1 60601G1 60701G1 60801G1 60902G1 61101G1 60401G1 60601G1 60801G1 60301G1 60701G1 60301G1 60502G1 60701G1 60301G1 60502G1 60701G1 60902G1 60301G1 60502G1 60701G1 61004G1 60301G1 60401G1 60601G1 60701G1 60805G1 61004G1 50204G1 50406G1 50202G1 50901G1 50204G1 60202G1 60502G1 60701G1 61101G1 60202G1 60506G1

Where was it sold?

US and Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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