Abbott Vascular: Medical Device Recall in 2017 - (Recall #: Z-2038-2017)

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 Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15

Product Classification:

Class I

Date Initiated: March 22, 2017
Date Posted: May 24, 2017
Recall Number: Z-2038-2017
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 61209G1 61209G2 61102G1 61102G1 61012G1 61209G1 61101G1 60415G1 61209G1 61102G1 61101G1 61101G1 61102G1 60415G1 61102G1 61101G1 60415G1 61209G1 61102G1 50415G1 50919G1 51110G1 61209G1 50919G1 51210G1 61101G1 61102G1 60415G1 61102G1 60415G1 61209G1

Distribution Pattern:

US and Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated