Lemaitre Embolectomy Catheter

• • Ongoing Z-0228-2023 FDA Class II ·initiated 30 Sep 2022

  Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

• 5 recalls, same reason

  • Terminated Z-0390-2016 FDA Class II ·initiated 21 Oct 2015
  • Terminated Z-0388-2016 FDA Class II ·initiated 21 Oct 2015
  • Terminated Z-0387-2016 FDA Class II ·initiated 21 Oct 2015
  • Terminated Z-0389-2016 FDA Class II ·initiated 21 Oct 2015
  • Terminated Z-0386-2016 FDA Class II ·initiated 21 Oct 2015

  Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

• 3 recalls, same reason

  • Terminated Z-0557-05 FDA Unclassified (pre-2012) ·initiated 7 Feb 2005
  • Terminated Z-0558-05 FDA Unclassified (pre-2012) ·initiated 7 Feb 2005
  • Terminated Z-0560-05 FDA Unclassified (pre-2012) ·initiated 7 Feb 2005

  Product sterility maybe compromised due to defective packaging

510(k) Number

K992368 ↗

FDA Product Code

DXE

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lemaitre Irrigation Catheter

  Class II

  FDA 510(k) K992933 Active Cleared 8 Mar 2000

• LeMaitre Occlusion Catheter

  Class II

  FDA 510(k) K992942 Active Cleared 13 Apr 2000

• Lemaitre-Bookwalter Vessel Devices

  Class II

  FDA 510(k) K912548 Active Cleared 18 Sep 1991

• Lemaitre Balloon Catheter with Irrigation

  Class II

  FDA 510(k) K992940 Active Cleared 22 Feb 2000

• The Samuels Retrograd Valvulotome

  Class II

  FDA 510(k) K932009 Active Cleared 21 Sep 1993

• Sterile LeMaitre Glow 'N Tell Tape

  Class II

  FDA 510(k) K932184 Active Cleared 22 Jul 1993

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