Mobicath Bi-Directional Guiding Sheath Model 1000182-Xxx

• • Terminated Z-2914-2016 FDA Class II ·initiated 19 Sep 2016 ·on shared 510(k) K101784

  FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.

• • Terminated Z-0611-2013 FDA Class II ·initiated 12 Nov 2012

  Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).

• • Terminated Z-0132-2013 FDA Class II ·initiated 24 Sep 2012

  We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K101784 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• OptiSeal™ Valved Peelable PTFE Introducer Kit

  Class IIa

  CE/MDD

• Z Flex-270TM Steerable Sheath

  Class II

  FDA 510(k) K112541 Active Cleared 7 Feb 2012

• Mobicath Bi-Directional Guiding Sheath

  Class II

  FDA 510(k) K130559 Active Cleared 24 May 2013

• Ptfe Peelable Introducer

  Class II

  FDA 510(k) K093023 Active Cleared 29 Oct 2009

• Mobicath Transseptal Needle

  Class II

  FDA 510(k) K111644 Active Cleared 3 Oct 2011

• Optiseal Enpath Valved Ptfe Peelable Introducer

  Class II

  FDA 510(k) K093232 Active Cleared 15 Mar 2010

See all devices from Great Batch Medical →