Recall Z-2459-2012
Greatbatch Medical · initiated September 6, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2459-2012
- Initiated
- September 6, 2012
- Posted by FDA
- September 26, 2012
- Terminated
- January 22, 2015
- Product code
- DRA – Catheter, Steerable
- Quantity
- 787
- Distribution
- Distributed in MA.
- Recalling firm
- Greatbatch Medical, Minneapolis, MN