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.
FDA Recall Z-2333-2008 · Posted 2008-09-24
Recalling FirmOscor, Inc.
Recall StatusTerminated
Product CodeDTB
Date Initiated2008-01-29
Date Terminated2008-11-14
Reason for Recall
The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
Firm 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 replacement.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc. · 2004-08-06K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc. · 2004-04-07K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSOscor, Inc. · 2001-05-22K872971PERMANENT MYOCARDIAL LEADS MP SERIESOscor Medical Corp. · 1988-02-12
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.