Enforcement Report - Week of October 3, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-2459-2012 |
| Classification | Class II |
| Code Info | Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843 |
| Product Distributed Qty | 787 |
| 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. |
Event Detail
| Event Id | 63141 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Greatbatch Medical |
| City | Minneapolis |
| State | MN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Distributed in MA. |
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