Reported Jan 2, 2013 · Terminated
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no.…
Greatbatch Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Greatbatch Medical · 2300 Berkshire Ln N · Minneapolis, MN · 55441-4575
Is this the product you have?
- 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.
- Lot codes and dates
- LOT
77 of 77 codes
R1701247R1713591W2046680W2046681W2072907W2078460W2084872W2098771W2102124W2102133W2102134W2108295W2108296W2108298W2108299W2125688W2125690W2132584W2132588W2132590W2138965W2143147W2143149W2143152W2145645W2145677W2145680W2145681W2151287W2151305W2151308W2156746W2156748W2156750W2156751W2162496W2162497W2162498W2162499W2167986W2167987W2167988W2167990W2172705W2172706W2172707W2172708W2172710W2172712W2177727W2177728W2177733W2177734W2184476W2184483W2184484W2184487W2190457W2190461W2190464
- LOT
- Amount recalled
- 10,201 units
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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