FDA Device recall Z-0753-2019
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate…
- FDA Device
- Class II
- terminated
- Published 2019-01-30
On 2019-01-30 the FDA classified a Class II recall of Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate… by Teleflex Medical, citing 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 fun….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0753-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-03 |
| Published | 2019-01-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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-o-lok ligating clips to soft tissue during laparoscopic surgery.
Reason
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.
Identifiers
| code_info | Batch/Lot Numbers: 73A1700531, 73B1700180, 73F1700583, 73F1700584, 73F1700585, 73H1700728, 73J1600394, 73J1700072, 73J1700073, 73J1700074, 73J1700554 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0753-2019%22
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