FDA Medical Device Recalls (openFDA)
Cordis Corporation: 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
- Recall number
- Z-0707-03
- Recalling firm
- Cordis Corporation
- 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
- Status
- Terminated
- Initiated
- 2003-02-03
- Posted
- 2003-04-02
- Terminated
- 2010-09-08
- Reason
- The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.
- 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
- 32000
- Distribution
- Product was distributed to 1141 user/medical facilities nationwide.
- Lot, serial or model codes
- All lot numbers for the referenced product numbers.
- 510(k) numbers
- ["K023217","K021898"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28