The Recall Desk

FDA (Devices) recall action 69965

Ev3, Inc. recalled 2 products on 2015-01-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-01-07
Critical
0
Units
38

Why these products were recalled

Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2015-01-07

    Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error

    Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected units were distributed internationally.

    Product
    ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-01-07

    Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error

    Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected devices were distributed internationally.

    Product
    ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
    Category
    Distribution
    0 states