Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath M
FDA device recall Z-0580-2010 · posted 2009-12-29 · Terminated
Recall details
- Recalling firm
- Greatbatch Medical
- 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.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- DTB
- Quantity affected
- 45 units
- Distribution
- CA and MN
- Date initiated
- 2009-09-01
- Date posted
- 2009-12-29
- Date terminated
- 2011-12-17
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DAIG PACEMAKER LEAD ADAPTOR (K870562) | Daig Corp. | 1987-03-03 |