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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Smart Control

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 Class 2 Device Recall Cordis Smart Controlsee related information
Date Initiated by FirmFebruary 03, 2003
Date PostedApril 02, 2003
Recall Status1 Terminated 3 on September 08, 2010
Recall NumberZ-0707-03
Recall Event ID 25712
510(K)NumberK021898 K023217 
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
ProductThe device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers. Product is packed in a Tyvek pouch and further packed into a shelf carton. Product Numbers: C06020SB, C06020MB, C06030SB, C06030MB, C06040SB, C06040MB, C06060SB, CO6060MB, C06080SB, C06080MB, C06100SB, C06100MB, C07020SB, C07020MB, C07030SB, C07030MB, C07040SB, C07040MB, C07060SB, C07060MB, C07080SB, C07080MB, C07100SB, CO7100MB, C08020SB, C08020MB, CO8030SB, C08030MB, C08040SB, C08040MB, C08060SB, C08060MB, C08080SB, C08080MB, C08100SB, C08100MB, C09020SB, C09020MB, C09030SB, C09030MB, C09040SB, C09040MB, C09060SB, C09060MB, C09080SB, C09080NB, C10020SB, C10020MB, C10030SB, C10030MB, C10040SB, C10040MB, C10060SB, C10060MB, C10080SB, C10080MB. Product number related to dimension as follows: C06020SB 6mm x 20mm x 80cm C06020MB 6mm x 20mm x 120cm C06030SB 6mm x 30mm x 80cm C06030MB 6mm x 30mm x 120cm C06040SB 6mm x 40mm x 80cm C06040MB 6mm x 40mm x 120cm C06060SB 6mm x 60mm x 80cm C06060MB 6mm x 60mm x 120cm C06080SB 6mm x 80mm x 80cm C06080MB 6mm x 80mm x 120cm C06100SB 6mm x 100mm x 80cm C06100MB 6mm x 100mm x 120cm C07020SB 7mm x 20mm x 80cm C07020MB 7mm x 20mm x 120cm C07030SB 7mm x 30mm x 80cm C07030MB 7mm x 30mm x 120cm C07040SB 7mm x 40mm x 80cm C07040MB 7mm x 40mm x 120cm C07060SB 7mm x 60mm x 80cm C07060MB 7mm x 60mm x 120cm C07080SB 7mm x 80mm x 80cm C07080MB 7mm x 80mm x 120cm C07100SB 7mm x 100mm x 80cm C07100MB 7mm x 100mm x 120cm C08020SB 8mm x 20mm x 80cm C08020MB 8mm x 20mm x 120cm C08030SB 8mm x 30mm x 80cm C08030MB 8mm x 30mm x 120cm C08040SB 8mm x 40mm x 80cm C08040MB 8mm x 40mm x 120cm C08060SB 8mm x 60mm x 80cm C08060MB 8mm x 60mm x 120cm C08080SB 8mm x 80mm x 80cm C08080MB 8mm x 80mm x 120cm C08100SB 8mm x 100mm x 80cm C08100MB 8mm x 100mm x 120cm C09020SB 9mm x 20mm x 80cm C09020MB 9mm x 20mm x 120cm C09030SB 9mm x 30mm x 80cm C09030MB 9mm x 30mm x 120cm C09040SB 9mm x 40mm x 80cm C09040MB 9mm x 40mm x 120cm C09060SB 9mm x 60mm x 80cm C09060MB 9mm x 60mm x 120cm C09080SB 9mm x 80mm x 80cm C09080MB 9mm x 80mm x 120cm C10020SB 10mm x 20mm x 80cm C10020MB 10mm x 20mm x 120cm C10030SB 10mm x 30mm x 80cm C10030MB 10mm x 30mm x 120cm C10040SB 10mm x 40mm x 80cm C10040MB 10mm x 40mm x 120cm C10060SB 10mm x 60mm x 80cm C10060MB 10mm x 60mm x 120cm C10080SB 10mm x 80mm x 80cm C10080MB 10mm x 80mm x 120cm
Code Information All lot numbers for the referenced product numbers.
FEI Number 1016427
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014
For Additional Information ContactDennis Donohoe, MD
786-313-2955
Manufacturer Reason
for Recall		The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.
FDA Determined
Cause 2		Other
ActionThe firm sent via Federal Express Overnight delivery, a notification letter entitled 'IMPORTANT PRODUCT INFORMATION ALERT' dated 2/3/2003 to all user hosptial accounts. The letter warns them of the possibility of partial deployment and how to avoid it. There is no request to stop using or to return the product. The firm considers the action a 'Safety Alert'.
Quantity in Commerce32000
DistributionProduct was distributed to 1141 user/medical facilities nationwide.
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 = FGE
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