Recall Z-1143-2020— Abbott Vascular
Class I · Terminated
Class I FDA medical device recall by Abbott Vascular, initiated 2020-01-29, terminated 2024-04-16. It names 2 FDA 510(k) clearances: K110134, K103153. Product: NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.. Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon..
- Recalling firm
- Abbott Vascular
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-01-29
- Terminated
- 2024-04-16
- Firm location
- Temecula, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K110134 — NC TREK RX CORONARY DILATATION CATHETER
- K103153 — VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Reason for recall
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Data sourced from openFDA. This site is unofficial and independent of the FDA.