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U.S. Department of Health and Human Services

Class 2 Device Recall Permanent Pacing Lead

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  Class 2 Device Recall Permanent Pacing Lead see related information
Date Initiated by Firm January 29, 2008
Date Posted September 24, 2008
Recall Status1 Terminated 3 on November 14, 2008
Recall Number Z-2333-2008
Recall Event ID 48678
510(K)Number K041809  K040569  K010787  K872971  
Product Classification Permanent Pacemaker Electrode - Product Code DTB
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.
Code Information 02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
Recalling Firm/
Manufacturer		 Oscor, Inc.
3816 De Soto Blvd.
Palm Harbor FL 34683-1618
For Additional Information Contact Mila Doskocil
727-937-2511 Ext. 133
Manufacturer Reason
for Recall		 The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
FDA Determined
Cause 2		 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 replacement.
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTB and Original Applicant = Oscor Inc.
510(K)s with Product Code = DTB and Original Applicant = OSCOR MEDICAL CORP.
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