FDA Device recall Z-2037-2017
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 10124…
- FDA Device
- Class I
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class I recall of NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 10124… by Abbott Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2037-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-03-22 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Vascular |
| Distribution | n/a |
Product
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
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.
Identifiers
| code_info | Lot Number 60414G1 60721G1 60208G1 60419G1 60420G1 60603G1 60906G1 61121G1 61121G2 60225G1 60229G1 60318G1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2037-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.