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Recall Observatory FDA recall evidence

Device product

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

Z-2038-2017

March 22, 2017

Class I

Product summary

Firm
Abbott Vascular
Event
Event 76841
Status
Terminated
Classification
Class I
Quantity
449,661 units total (132,040 units in US)
Official record key
device-enforcement:Z-2038-2017

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.