Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
FDA Recall Z-0580-2010 · Posted 2009-12-29
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Recalling FirmGreatbatch Medical
Recall StatusTerminated
Product CodeDTB
Date Initiated2009-09-01
Date Terminated2011-12-17
Product Quantity45 units
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.
Firm 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.
Root Cause
Component change control
Distribution Pattern
CA and MN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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