Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, an
FDA device recall Z-2333-2008 · posted 2008-09-24 · Terminated
Recall details
- Recalling firm
- Oscor, Inc.
- Reason for recall
- The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
- Action taken
- On January 24, 08, Oscor sent out a letter to doctors/ customers with the subject line of "Re: Market Withdrawal of Permanent Pacing Leads due to the lead connector insertion difficulty," stating they experienced some difficulties with the insertion of pacing lead connectors into the pacemaker headers. They asked that customers review the inventory list and remove all products, whose serial numbers match the serial numbers on the list and have not been implanted. Also, customers should call Oscor customer service for a Return Goods Product number and return the product back to the firm for replacement.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTB
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-01-29
- Date posted
- 2008-09-24
- Date terminated
- 2008-11-14
- Location
- Palm Harbor, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERMANENT PACING LEAD, MODEL PY2 (K041809) | Oscor, Inc. | 2004-08-06 |
| PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (K040569) | Oscor, Inc. | 2004-04-07 |
| PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787) | Oscor, Inc. | 2001-05-22 |
| PERMANENT MYOCARDIAL LEADS MP SERIES (K872971) | Oscor Medical Corp. | 1988-02-12 |