Recall Z-2333-2008
Oscor, Inc. · initiated January 29, 2008
Product
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, implantable pulse generator/pacemaker.
Codes / lots: 02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
Reason for recall
The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2333-2008
- Initiated
- January 29, 2008
- Posted by FDA
- September 24, 2008
- Terminated
- November 14, 2008
- Product code
- DTB – Permanent Pacemaker Electrode
- Distribution
- Nationwide Distribution
- Recalling firm
- Oscor, Inc., Palm Harbor, FL