The Recall Desk

FDA (Devices) recall action 65831

Medtronic Inc. Cardiac Rhythm Disease Management recalled 3 products on 2013-09-04

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-09-04
Critical
0
Units
14,198

Why these products were recalled

Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

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.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Defective Suction Wand

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands recalled by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmo
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Component Issue

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indica
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
    Category
    Distribution
    4 states