Z-0287-2011

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

Name: Z-0287-2011 enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF...
Creator: Greatbatch Medical
Published: 2010-05-13
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2010-05-13 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in... on 2010-05-13. The reason FDA records is "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...". 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-0287-2011
Status: Terminated
Initiated: 2010-05-13
Posted: 2010-11-02
Terminated: 2012-05-10
Recalling firm: Greatbatch Medical
Product: enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
Product code: DTB Permanent Pacemaker Electrode
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 34
Distribution: Worldwide Distribution: to USA and Europe, through distributor in MN.
Product codes and lots: serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.

Product code DTB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)