enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm.

FDA device recall Z-0287-2011 · posted 2010-11-02 · Terminated

Recall details

Recalling firm

Greatbatch Medical

Reason for recall

The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.

Action taken

Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor. The letter described the problem and product involved, and gave the action required which included: 1) immediately discontinue distribution of the units and return any unused units to Greatbatch Medical. 2) Reconcile medical recordsbetween BSC and Greatbatch Medical to confirm implant data 3) Confirm pulse generator type (bipoloar, unipolar, or unknown) used with each serial number listed Greatbatch will work with customers to contact physicians as necessary regarding patient monitoring. Greatbatch Medical can be contacted at 763-951-8312.

Root cause

Employee error

Status

Terminated

Product code

DTB

Quantity affected

34

Distribution

Worldwide Distribution: to USA and Europe, through distributor in MN.

Date initiated

2010-05-13

Date posted

2010-11-02

Date terminated

2012-05-10

Location

Minneapolis, MN