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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 12, 2004
Date PostedAugust 07, 2004
Recall Status1 Terminated 3 on November 22, 2004
Recall NumberZ-1315-04
Recall Event ID 29517
510(K)NumberK031610 
Product Classification Catheter, Peripheral, Atherectomy - Product Code MCW
ProductProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
Code Information Lot Numbers--Exp.Date: M354580 -- 2004-03; M357300-- 2004-05; M401160-- 2004-08; M401170 -- 2004-08; M413790 --2004-09; M414240 -- 2004-09; M437260 -- 2004-10.
FEI Number 3003071194
Recalling Firm/
Manufacturer		 Datascope Interventional Products Division
1300 Macarthur Blvd
Mahwah NJ 07430
For Additional Information ContactPatrice Napoda
201-995-8758
Manufacturer Reason
for Recall		The motor may fail to activate when the on/off switch is pressed.
FDA Determined
Cause 2		Other
ActionLetter dated July 16, 2004 was mailed via US mail, return receipt requested.
Quantity in Commerce892
DistributionThe product was shipped nationwide to 243 direct accounts. and to 7 government accounts.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MCW
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