Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D14001
FDA device recall Z-0611-2013 · posted 2012-12-22 · Terminated
Recall details
- Recalling firm
- Greatbatch Medical
- 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).
- Action taken
- Biosense Webster sent an "Urgent Field Safety Notice" dated November 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Voluntary Field Removal Certification Form was attached for customers to complete and return. Contact the firm at 800-729-9010 for questions related to this issue.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 10,201 units
- Distribution
- 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
- Date initiated
- 2012-11-12
- Date posted
- 2012-12-22
- Date terminated
- 2014-05-15
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX (K101784) | Great Batch Medical | 2010-11-26 |