Recall Z-0581-2010 ยท DTB Permanent Pacemaker Electrode
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.
| Date | Dec 29, 2009 (initiated Sep 1, 2009) |
| Status | Terminated |
| Reason | 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. |
| 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 | 35 units |
| Distribution | CA and MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925099 | POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA Possis Medical, Inc., Jun 22, 1993 |