Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D14001
FDA device recall Z-0132-2013 · posted 2012-10-24 · Terminated
Recall details
- Recalling firm
- Greatbatch Medical
- Reason for recall
- 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.
- Action taken
- The firm, Greatbatch, Ltd., sent an "URGENT CUSTOMER NOTIFICATION Medical Device - Voluntary Field Safety Notice" dated Monday, September 24, 2012 to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to read the "Description of the Problem" and "Recommendations for Clinical Use" sections carefully; complete and return the attached Field Action Acknowledgement Form via mail to: Biosense Webster, Incl, 15715 Arrow Highway, Irwindale, CA 91706; Attn: Recall Coordinator, or Fax to: (909) 839-8514; pass on this notice to anyone in your facility that needs to be informed; maintain awareness of this communication until information has been incorporated into the device labeling, and to avoid the catheter inside the MobiCath Bi-Directional Guiding Sheath from "self-advancing", physicians should reposition the catheter handle when manipulating the catheter in and out of the sheath. Greatbatch, Ltd. is updating the MobiCath Bi-Directional Guiding Sheath Instructions For Use (IFU) accordingly. Supplemental information will be provided with future shipments of these devices, until the revised IFU is available. For questions related to the issue please contact your Biosense Webster representative or call (800) 729-9010, Monday through Friday from 9:00 AM to 6:00 PM EST. For questions related to the Acknowledgment Form and its return, please contact Field Action Coordinator at (909) 839-8468.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 9040
- Distribution
- Nationwide distribution: CA only.
- Date initiated
- 2012-09-24
- Date posted
- 2012-10-24
- 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 |