Z-0581-2010

Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been...

Name: Z-0581-2010 Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been...
Creator: Greatbatch Medical
Published: 2009-09-01
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2009-09-01 / Terminated

FDA source

Greatbatch Medical began a recall of Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by... on 2009-09-01. The reason FDA records is "The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0581-2010
Status: Terminated
Initiated: 2009-09-01
Posted: 2009-12-29
Terminated: 2011-12-17
Recalling firm: Greatbatch Medical
Product: Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner 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 silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
FDA root cause: Component change control
Action: Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.
Quantity in commerce: 35 units
Distribution: CA and MN
Product codes and lots: Serial Numbers: 148399, 148400, 148401, 148402, 148403, 148404, 148405, 148406, 148407, 148408, 148409, 148410, 148411, 148412, 148413, 148414, 148415, 148416, 148417, 148418, 148419, 148420, 148421, 148422, 148423, 148424, 148427, 148430, 148431, 148433, 148434, 148435, 148436, 148437, 148438.

Product code DTB

K925099Class IIIPossis Medical Myopore Bipolar Sutureless MycardiaPossis Medical, Inc. / cleared 1993-06-22

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)