Greatbatch Medical 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Greatbatch Medical
Lot Codes / Batch Numbers
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.
Products Sold
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.
Greatbatch Medical is recalling Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package h due to The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MN
Page updated: Jan 10, 2026