Percuvance — Class II medical device recall Z-0754-2019
Terminated recall by Teleflex Medical, reported 2019-01-30, distributed nationwide. There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break
| Recall number | Z-0754-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2018-01-03 |
| Classified | 2019-01-18 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2020-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CN, CZ, DE, ES, FR, GB, IE, IR, IT, JP, LB, NL, QA, RO, SA, SG, TR, TW |
| Quantity | 1,962 units |
| Reason classes | device malfunction |
| Lot numbers | 73A1700535, 73B1600170, 73B1700073, 73B1700523, 73B1700646, 73C1600058, 73C1600706, 73D1600482, 73F1600086, 73G1600207, 73G1600468, 73G1600573, 73G1700041, 73G1700311, 73G1700577, 73H1600509, 73H1700513, 73H1700526, 73H1700531, 73H1700532, 73J1700100, 73J1700553, 73M1600016, 73M1600027, 73M1600231 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0754-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.