Recall Z-0205-2015— Medtronic Vascular
Class II · Terminated
Class II FDA medical device recall by Medtronic Vascular, initiated 2014-10-13, terminated 2015-02-18. It names one FDA 510(k) clearance: K021256. Product: Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K. Reason: Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the.
- Recalling firm
- Medtronic Vascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-13
- Terminated
- 2015-02-18
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Reason for recall
Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the
Data sourced from openFDA. This site is unofficial and independent of the FDA.