Recall Z-2333-2008 ยท DTB Permanent Pacemaker Electrode
Oscor, Inc.
Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, im
| Date | Sep 24, 2008 (initiated Jan 29, 2008) |
| Status | Terminated |
| Reason | The O-rings are over tolerance making it hard to connect the leads to the pacemaker. |
| Root cause | Nonconforming Material/Component |
| Action | 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 r |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS Oscor, Inc., May 22, 2001 |
| K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU Oscor, Inc., Apr 7, 2004 |
| K041809 | PERMANENT PACING LEAD, MODEL PY2 Oscor, Inc., Aug 6, 2004 |
| K872971 | PERMANENT MYOCARDIAL LEADS MP SERIES Oscor Medical Corp., Feb 12, 1988 |