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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific, Z Flex 270, Steerable Sheath

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  Class 2 Device Recall Boston Scientific, Z Flex 270, Steerable Sheath see related information
Date Initiated by Firm September 06, 2012
Date Posted September 26, 2012
Recall Status1 Terminated 3 on January 22, 2015
Recall Number Z-2459-2012
Recall Event ID 63141
510(K)Number K112541  
Product Classification Catheter, steerable - Product Code DRA
Product Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441.

To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
Code Information Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Minneapolis MN 55441-4575
For Additional Information Contact
763-951-8181
Manufacturer Reason
for Recall		 During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Greatbatch Medical sent a "SAFETY ALERT-Z-FLEX-270 STEERABLE SHEATH" letter dated September 6, 2012 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. The letter advised the customer to communicate with their customers to assure the that the recalled sheath model is not used in conjunction with cryoablation catheters. Contact the firm at 763-951-8214 for questions regarding this issue.
Quantity in Commerce 787
Distribution Distributed in MA.
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 = DRA and Original Applicant = Greatbatch Medical
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