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U.S. Department of Health and Human Services

Class 2 Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis

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 Class 2 Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesissee related information
Date Initiated by FirmMarch 19, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 08, 2012
Recall NumberZ-1075-04
Recall Event ID 29074
510(K)NumberK023248 
Product Classification unknown device name - Product Code MEW
ProductThe product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. Ref. Baloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D
Code Information Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026
FEI Number 3014148220
Recalling Firm/
Manufacturer		 Orbus Medical Technologies Inc
5363 NW 35th Ave
Fort Lauderdale FL 33309-6315
For Additional Information ContactJames Clossick
954-730-0711
Manufacturer Reason
for Recall		BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.
FDA Determined
Cause 2		Other
Action Orbus, the recalling firm issued a recall letter on March,19 2004 to their own label distributer, Edwards Lifesciences, requesting the return of unused product. Also Orbus provided the own label distributer with a sample sub-recall letter for them to send to users/hospital accounts. Sub-accounts were asked to return product to Edwards Lifesciences.
Quantity in Commerce22
DistributionProduct was shipped to one own label distributer in California.
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) Database510(K)s with Product Code = MEW
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