Recall Z-0611-2013— Greatbatch Medical

Name: FDA recall Z-0611-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-12

Class II · Terminated

Class II FDA medical device recall by Greatbatch Medical, initiated 2012-11-12, terminated 2014-05-15. It names one FDA 510(k) clearance: K101784. Product: Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.. Reason: 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)..

Recalling firm: Greatbatch Medical
Classification: Class II
Status: Terminated
Initiated: 2012-11-12
Terminated: 2014-05-15
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K101784 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXXGreat Batch Medical·cleared 2010-11-26

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

Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.