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U.S. Department of Health and Human Services

Class 2 Device Recall Biosense Webster MobiCath BiDirectional Guiding Sheath, Model D140010

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  Class 2 Device Recall Biosense Webster MobiCath BiDirectional Guiding Sheath, Model D140010 see related information
Date Initiated by Firm February 15, 2017
Create Date July 29, 2017
Recall Status1 Terminated 3 on May 09, 2019
Recall Number Z-2782-2017
Recall Event ID 76514
510(K)Number K130559  
Product Classification Introducer, catheter - Product Code DYB
Product Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve).

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 kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.
Code Information Model D140010, Lots: W3332609, W3338632, W3338635, W3338707, W3348350, W3348351, W3352503, W3359665, W3363850, W3363851, W3370052, W3374699, W3374700, W3379647, W3379650, W3384700, W3384701, W3390549, W3390551, W3397877, W3397879, W3397950, W3407814, W3407815, W3436351, W3436355, W3436356, W3436358, W3441735, W3441737, W3446767, W3446769, W3449392, W3451862, W3451863, W3455438,  W3455439, W3455440, W3459354, W3462467, W3462470, W3470335,  W3470336, W3483637, W3493240, W3497507, W3501348, W3501349,  W3581648, X3489776, X3497121, X3497510, X3501344, X3501345, X3503248,  X3507599, X3514814, X3518116, X3565743, X3581652, X3586059, X3592497.   Model D140011, Lots:  
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Plymouth MN 55441-4575
For Additional Information Contact local Greatbath Medical representative
763-951-8184
Manufacturer Reason
for Recall		 One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
FDA Determined
Cause 2		 Process control
Action Consignee was sent a Greatbatch "Urgent Medical Device Recall" letter dated February 15, 2017 via UPS and email . The letter was addressed to Biosense Webster, Inc. The letter described the product involved in the recall, Reason for Recall, Risk to Health,& Instructions to Biosense Webster. Advised consignee to quarantine and return the devices, complete and return the field Recall Response Form to Stericycle, and to communicate the recall to their customers and end users. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8184 from 8:00 AM (CST) to 5:00 PM (CST), or e-mail us at FieldActionCenter@Greatbatch.com
Quantity in Commerce 11,360
Distribution CA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Greatbatch Medical
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