Z-0707-03

The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS...

Name: Z-0707-03 The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS...
Creator: Cordis Corporation
Published: 2003-02-03
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2003-02-03 / Terminated

FDA source

Cordis Corporation began a recall of The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers. Product is packed in a... on 2003-02-03. The reason FDA records is "The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0707-03
Status: Terminated
Initiated: 2003-02-03
Posted: 2003-04-02
Terminated: 2010-09-08
Recalling firm: Cordis US Corp.
Product: The 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
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.
FDA root cause: Other
Action: The 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 commerce: 32000
Distribution: Product was distributed to 1141 user/medical facilities nationwide.
Product codes and lots: All lot numbers for the referenced product numbers.

Product code FGE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)