Z-2459-2012Class II

Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific...

Name: Z-2459-2012 Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific...
Creator: Greatbatch Medical
Published: 2012-09-06
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2012-09-06 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA... on 2012-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2459-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-06
Posted: 2012-09-26
Terminated: 2015-01-22
Recalling firm: Greatbatch Medical
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.
Product code: DRA Catheter, Steerable
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 787
Distribution: Distributed in MA.
Product codes and lots: Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2459-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2459-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-26

Product code DRA

K112541Class IIZ Flex-270Tm Steerable SheathGreat Batch Medical / cleared 2012-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)