Recall Z-2459-2012— Greatbatch Medical

Name: FDA recall Z-2459-2012
Creator: U.S. Food and Drug Administration
Published: 2012-09-06

Class II · Terminated

Class II FDA medical device recall by Greatbatch Medical, initiated 2012-09-06, terminated 2015-01-22. It names one FDA 510(k) clearance: K112541. 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.. Reason: 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..

Recalling firm: Greatbatch Medical
Classification: Class II
Status: Terminated
Initiated: 2012-09-06
Terminated: 2015-01-22
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K112541 — Z FLEX-270TM STEERABLE SHEATHGreat Batch Medical·cleared 2012-02-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.