Greatbatch Medical: Medical Device Recall in 2012 - (Recall #: Z-2459-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 6, 2012

Date Posted: October 3, 2012

Recall Number: Z-2459-2012

Event ID: 63141

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.

Status: Terminated

Product Quantity: 787

Code Information:

Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843

Distribution Pattern:

Distributed in MA.

Voluntary or Mandated:

Voluntary: Firm initiated