Home / Recalls / Greatbatch Medical / Z-2459-2012

Z-2459-2012 Class II Terminated

Recalled by Greatbatch Medical — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
October 3, 2012
Initiation Date
September 6, 2012
Termination Date
January 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
787

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.

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.

Distribution Pattern

Distributed in MA.

Code Information

Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843

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