Biosense Webster MobiCath Bi-Directional Guiding Sheath — Class II medical device recall Z-0611-2013
Terminated recall by Greatbatch Medical, reported 2013-01-02, distributed in AK, AL, AZ, CA, CO, CT, DC, FL…. Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths u
| Recall number | Z-0611-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greatbatch Medical, Minneapolis, MN, United States |
| Recall initiated | 2012-11-12 |
| Classified | 2012-12-22 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2014-05-15 |
| Distributed | AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, ES, FI, FR, GB, GR, HU, IE, IL, IT, NO, SE |
| Quantity | 10,201 units |
| Lot numbers | 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 and 37 more |
| Model numbers | D140010, D140011 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0611-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.