The Recall Desk

FDA (Devices) recall action 90892

Covidien, LP recalled 2 products on 2022-11-23

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
2022-11-23
Critical
0
Units
148,636

Why these products were recalled

Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.

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

  • HighFDA (Devices)··2022-11-23

    Endo Stitch V-Loc 180 Sutures Recalled for Needle Breakage During Use

    Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.

    Product
    Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-11-23

    Endo Stitch V-Loc surgical sutures recalled due to needle breakage

    Covidien is recalling Endo Stitch V-Loc PBT non-absorbable surgical sutures due to 210 reports of needles breaking during use. Breaking needles may leave fragments in patients, potentially causing tissue injury or requiring additional imaging.

    Product
    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
    Category
    Distribution
    0 states