The Recall Desk

FDA (Devices) recall action 77144

Medtronic recalled 8 products on 2017-06-21

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products
8
Announced
2017-06-21
Critical
0
Units
3,827,720

Why these products were recalled

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

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

1–8 of 8

  • ModerateFDA (Devices)··2017-06-21

    Medtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal

    Medtronic is recalling specific Polysorb suture products because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60"
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-06-21

    Medtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect

    Medtronic is recalling 478,465 units of the Pacemaker Angio X3 because an incomplete seal on the inner package may cause the suture material to degrade prematurely.

    Product
    SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-06-21

    Medtronic Recalls MAXON Sutures Due to Potential Incomplete Seal

    Medtronic is recalling specific MAXON sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-06-21

    Medtronic Recalls Best Practice Kits Due to Potential Seal Defects

    Medtronic is recalling Best Practice Kits because an incomplete seal may cause the suture material to degrade prematurely.

    Product
    Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-06-21

    Medtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal

    Medtronic is recalling BIOSYN sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-06-21

    Medtronic Recalls Endo Stitch Polysorb Sutures Due to Seal Defect

    Medtronic is recalling specific Endo Stitch Polysorb sutures because an incomplete inner package seal may cause the material to degrade prematurely.

    Product
    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
    Category
    Distribution
    1 state