Events

Recall of 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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30826
  • Event Risk Class
    Class 3
  • Event Number
    Z-0555-05
  • Event Initiated Date
    2004-11-18
  • Event Date Posted
    2005-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36664
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Coronary Drug-Eluting Stent - Product Code NIQ
  • Reason
    Inventory control stickers had incorrect expiration date. the stickers stated the expiration date was november 2004 instead of october 2004.
  • Action
    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.

Device

Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and C...
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed nation wide.
  • Product Description
    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
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA