Teleflex Medical recalls Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for t…

Recall date

January 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0754-2019

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.