Abbott Vascular: Medical Device Recall in 2017 - (Recall #: Z-2039-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: March 22, 2017

Date Posted: May 24, 2017

Recall Number: Z-2039-2017

Event ID: 76841

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.

Status: Terminated

Product Quantity: 449,661 units total (132,040 units in US)

Code Information:

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

Distribution Pattern:

US and Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated