FDA Medical Device Recalls (openFDA)
Ev3, Inc: ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, ev3, 4600 Nathan lane North, Plymouth, MN 55442, Catalog Number: 90-1431-002. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-36, Catalog Number: 90-1504-002 (not approved within USA).
- Recall number
- Z-1125-2008
- Recalling firm
- Ev3, Inc
- Product
- ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, ev3, 4600 Nathan lane North, Plymouth, MN 55442, Catalog Number: 90-1431-002. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-36, Catalog Number: 90-1504-002 (not approved within USA).
- Status
- Terminated
- Initiated
- 2008-01-18
- Posted
- 2008-05-06
- Terminated
- 2008-11-04
- Reason
- Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Root cause
- Labeling Change Control
- Action
- ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."
- Quantity
- 11
- Distribution
- Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
- Lot, serial or model codes
- Lot Numbers: 2722702, 2099726, and 1831865
- 510(k) numbers
- ["K980290"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2183870
- Firm city
- Plymouth
- Firm state
- MN
- 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