# FDA recall Z-0754-2019

> **Teleflex Medical** · Class II · device recall initiated 2018-01-03.

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

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0754-2019
- **Recalling firm:** Teleflex Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-03
- **Report date:** 2019-01-30
- **Termination date:** 2020-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0754-2019

## Citation

> AI Analytics. FDA recall Z-0754-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0754-2019. Source: US FDA. Licensed CC0.

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