Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One
FDA device recall Z-2459-2012 · posted 2012-09-26 · Terminated
Recall details
- Recalling firm
- Greatbatch Medical
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DRA
- Quantity affected
- 787
- Distribution
- Distributed in MA.
- Date initiated
- 2012-09-06
- Date posted
- 2012-09-26
- Date terminated
- 2015-01-22
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Z FLEX-270TM STEERABLE SHEATH (K112541) | Great Batch Medical | 2012-02-07 |