FDA Device recall Z-1130-2020
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is ind…
- FDA Device
- Class I
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class I recall of NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is ind… by Abbott Vascular, citing coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1130-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-01-29 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Vascular |
| Distribution | n/a |
Product
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)
Reason
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Identifiers
| code_info | Device Identifier/GTIN: 08717648152078 Part Number: 1012453-15 Lot Numbers: 90815G1 91008G1 90816G1 91009G1 90828G1…Device Identifier/GTIN: 08717648152078 Part Number: 1012453-15 Lot Numbers: 90815G1 91008G1 90816G1 91009G1 90828G1 91020G1 90904G1 91026G1 90920G1 91109G1 90926G1 91117G1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1130-2020%22
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