Reported Oct 31, 2012 · 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
115 of 115 codes
Lot no.: W2046680W2046681W2072907W2078460W2084872W2098770W2098771W2102124W2102128W2102133W2102134W2108295W2108296W2108298W2108299W2108300W2125688W2125690W2132584W2132588W2132590W2138965W2143146W2143147W2143149W2143152W2145645W2145677W2145680W2145681W2151287W2151305W2151308W2156746W2156748W2156750W2156751W2162494W2162496W2162497W2162498W2162499W2167985W2167986W2167987W2167988W2167990W2172705W2172706W2172707W2172708W2172710W2172712W2177727W2177728W2177729W2177730W2177733W2177734W2184476
- Amount recalled
- 9040
Where it was sold
- Nationwide
- CA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Greatbatch Medical recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.