—#36664

Product

Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx

FDA product code: NIQ — Coronary Drug-Eluting Stent
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Lot # 50704127, 50804011, 40804419, 40804422, 40804454, 40904372, 50704295, X0704425, X0804127, X0904342, 40904373, A0804001, A0804816, X0904265, 40904407, X0704674, X0704943, A0804485, X0804498, A0804786, A0804849, 50704343, 50704422, X0704677, A0804002, A0904352, 50704126, A0804006, 40804658, 40904376, 50804311, 50804326, 40804467, X0804725, A0804846, 40904398, 50704344, A0804150, 50804168, X0804215, 40804453, X0904164, 40904400, A0904471, 40804200, A0904347, 40904409, A0904703, X0804723, A0804944, 50704423, 40804034, 50804211, 40804471, 40804477, 50804309, 40804433, X0804442, X0704098, 50704144, 50704282, 50704424, X0904073, A0904738, X0804214, A0804948, A0904349, 40904404, 40904413, A0904807, X0704825, A0904808, X0704961, 50804312, X0804370, 40804479, X0804495, A0804847, 40804201, X0804260, 40904369, 40904412, A0704263, 50704442, A0704528, 50804416, X0804724, A0804946, 40904350, 40904351, 50704446, X0704575, X0704826, 40804434, 40804465, 40804615, 40904375, X0604561, X0704819, 40804033, 40804202, 40804421, A0804486, X0904122, 40904378, A0904607, A0904701, 50704443, A0704629, X0704944, 40804431, 40804473, X0804496, 40904322, A0904348, 40904367, A0904476, A0904477, A0904720, A0904775, 50704125, X0704428, 50704441, X0704577, A0704631, 40804032, X0804126, X0804390, 40804472, A0904034, 40904321, 40904333, 40904334, 40904353, A0904696, X0704241, 50804313, 50804457, 40804659, A0804945, 40904379, A0904635, A0904636, 50704570, X0704964, A0804198, A0804203, X0804369, X0804392, 40804418, X0804630, A0804970, X0904121, 40904338, A0904483, A0904484, A0904488, X0704820, X0704945, A0804008, 50804165, 40804203, 50804417, 40804429, A0804568, X0804629, X0904119, X0904120, 40904339, 40904340, 40904374, A0904491, A0904492, 40904853, 50804166, A0804201, 40804432, 40804481, A0804567, X0804631, X0804882, 40904382, A0904719, A0904739, A0904876, 50704445, X0704821, X0804721, 40804913, 40904342, 40904365, A0904495, A0904707, A0904858, A0904875, A0804005, X0804086, 50804213, X0804722, 40904366, A0904497, A0904498, A0904736, A0904774, 40904854, X0704962, A0804004, A0804303, 40804437, A0904346, 40904368, A0904500, A0904860, A0704096, 50704366, 50704444, A0804009, 40904320, A0904698, A0904809, A0904859, 50704027, X0704307, A0804007, A0804149, 50804310, 40804430, X0804441, X0804497, 40904345, 40904364, A0904501, A0904699, X0704673, X0704824, A0804388, X0804689, X0804878, X0904237, 40904385, 50704425, X0704822, 50804418, 40804420, X0804690, A0804757, A0804817, 40904347, 40904348, X0704963, A0804199, A0804246, 40904354, 40904377, 40904386, A0904547.

Why it was recalled

Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.

Root cause (FDA determination)

Other

Action the firm took

The firm issued a removal of Cypher Product with Incorrect Inventory UBD Sticker letter to its customers in November 2004. The letter instructed them to return the product for credit. It also had an acknowledgement form and requested the consignees complete the acknowledgement form and fax back to Cordis. The firm intends to destroy the returned product.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Distributed nation wide.

Timeline

Recall initiated: 2004-11-18
Posted by FDA: 2005-02-18
Terminated: 2008-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36664. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.