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.
FDA Recall Z-2459-2012 · Posted 2012-09-26
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Recalling FirmGreatbatch Medical
Recall StatusTerminated
Product CodeDRA
Date Initiated2012-09-06
Date Terminated2015-01-22
Product Quantity787
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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