FDAJanuary 3, 2018device
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-o-lok ligating clip...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
teleflex medicalteleflex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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