Launcher LA6AL20A

• 4 recalls, same reason

  • Terminated Z-1247-2021 FDA Class II ·initiated 15 Jan 2021
  • Terminated Z-1248-2021 FDA Class II ·initiated 15 Jan 2021
  • Terminated Z-1246-2021 FDA Class II ·initiated 15 Jan 2021
  • Terminated Z-1245-2021 FDA Class II ·initiated 15 Jan 2021

  Sterility may be compromised due to an unsealed pouch

• • Terminated Z-0205-2015 FDA Class II ·initiated 13 Oct 2014

  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

• • Terminated Z-1564-2013 FDA Class II ·initiated 12 Jun 2013

  Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.

• 46 recalls, same reason

  • Terminated Z-0952-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1003-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0942-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0954-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1001-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0961-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1005-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0955-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0997-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0946-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1004-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0937-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0953-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1007-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0950-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0965-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0957-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0949-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0963-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1019-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0998-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0968-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1000-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1006-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0964-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0939-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0945-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0966-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0938-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0940-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0951-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0962-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1002-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0941-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1008-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0996-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0999-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0956-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0944-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0948-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0958-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0947-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0959-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0943-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0967-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-0960-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006

  Potential for non-sterility due to loss of package integrity

Trade Name

Launcher

Generic Name

Vascular guide-catheter, single-use

Model / Reference

LA6AL20A

Primary DI / UDI-DI

00613994820228

510(k) Number

K021256 ↗

FDA Product Code

DQY

GMDN Term

Vascular guide-catheter, single-use

Device Class

Class II

Regulation Number

870.1250

GUDID distribution status

In Commercial Distribution

Size

Length — 110.0 Centimeter

Catheter Gauge — 6.0 French

Category: Vascular guide-catheter, single-use

• Pacific™ Plus

  Class IIa

  CE/MDR

• Vanta™ AdaptiveStim™

  Class III

  CE/MDR G70 039709 1363 Active Valid to Sep 2031

• Amphirion™ Deep

  Class IIa

  CE/MDR

• Sprint Quattro Secure S®

  Active implantable (AIMDD)

  CE/AIMDD

• Admiral™ Xtreme

  Class IIa

  CE/MDR

• Micra™

  Active implantable (AIMDD)

  CE/AIMDD

See all devices from Medtronic, Inc. →