The Recall Desk

FDA (Devices) recall action 81909

Teleflex Medical recalled 2 products on 2019-01-30

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
2019-01-30
Critical
0
Units
3,713

Why these products were recalled

There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

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

  • SevereFDA (Devices)··2019-01-30

    Teleflex Percuvance Percutaneous Shaft Recall for Potential Tip Breakage

    Teleflex Medical is recalling Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially compromising the tool's security.

    Product
    Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-01-30

    Teleflex Percuvance Percutaneous Shaft Recall Due to Tip Breakage Risk

    Teleflex Medical is recalling 1,962 units of Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially requiring surgical intervention.

    Product
    Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver He
    Category
    Distribution
    0 states