Home / Recalls / Greatbatch Medical / Z-0611-2013

Z-0611-2013 Class II Terminated

Recalled by Greatbatch Medical — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
January 2, 2013
Initiation Date
November 12, 2012
Termination Date
May 15, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,201 units

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).

Distribution Pattern

Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA

Code Information

LOT: R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588.

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  • Z-2781-2017 Class II — ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 (November 11, 2016)
  • Z-1190-2017 Class II — Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable (October 19, 2016)
  • Z-0623-2017 Class II — Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Co (September 8, 2016)
  • Z-0367-2017 Class I — Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl06 (August 2, 2016)
  • Z-1882-2016 Class II — Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Cus (April 26, 2016)
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  • Z-1884-2016 Class II — Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed b (April 26, 2016)
  • Z-1614-2014 Class II — Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Orde (April 28, 2014)