Teleflex — Class II medical device recall Z-0059-2018
Terminated recall by Teleflex Medical, reported 2017-11-08, distributed nationwide. Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the too
| Recall number | Z-0059-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2017-10-18 |
| Classified | 2017-10-31 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2020-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, HK, JP, KR, SG |
| Quantity | 3,904 units |
| Reason classes | device malfunction |
| Lot numbers | 73E1700793, 73E1700794, 73E1700796, 73E1700798, 73G1700271, 73G1700272, 73G1700273, 73G1700515, 73H1700081, 73H1700082, 73H1700083, 73H1700084, 73H1700247, 73H1700367, 73H1700569 |
| Model numbers | PCVGG5, PCVHCA5, PCVJG5, PCVMD5, PCVSC5 |
Product
Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 (e) 5 mm Scissors, Catalog Number PCVSC5 The Percuvance Percutaneous Surgical System is a family of instruments used to perform laparoscopic procedures. Without the need for additional insertion conduits (trocars), the 2.9mm insulated Shafts are inserted percutaneously with the assistance of an Introducer needle tool tip. The Shaft is then advanced retrograde through a 5mm, or larger, port to facilitate the extracorporeal attachment of interchangeable Tool Tips. These interchangeable tools can be used to grasp, retract, manipulate, cut, coagulate and deliver Hem-o-lok¿ ligating clips to soft tissue. Each Percuvance System Handle includes an integrated male cautery adapter that can be connected to most monopolar electrosurgical units (ESU) via a standard 4mm monopolar cable.
Reason for recall
Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.
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-0059-2018. 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.