Z-2459-2012 Class II Terminated
FDA device recall Z-2459-2012 was initiated by Greatbatch Medical on September 6, 2012 and is designated Class II. 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… The recall status is terminated (terminated January 22, 2015). Affected quantity: 787.
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