Z-0059-2018Class II

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper...

Name: Z-0059-2018 Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper...
Creator: Teleflex Medical
Published: 2017-10-18
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-10-18 / Terminated

FDA source

Teleflex Medical began a recall of Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector... on 2017-10-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0059-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-18
Posted: 2017-10-31
Terminated: 2020-10-06
Recalling firm: Teleflex Medical
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
FDA root cause: Under Investigation by firm
Action: Teleflex sent an Urgent Medical Device Recall 1st Notification letter dated October 18, 2017, via FedEx. The customers were instructed to take the following actions : 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter." For further questions please call (847) 572- 8014.
Quantity in commerce: 3904 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.
Product codes and lots: (a) Catalog Number PCVJG5, Lot Numbers: 73E1700794, 73G1700271, 73G1700515, 73H1700081, 73H1700367 (b) Catalog Number PCVMD5, Lot Numbers: 73E1700796, 73G1700273, 73H1700083 (c) Catalog Number PCVHCA5, Lot Numbers: 73E1700798, 73H1700084 (d) Catalog Number PCVGG5, Lot Numbers: 73E1700793, 73G1700272, 73H1700082, 73H1700247 (e) Catalog Number PCVSC5, Lot Number: 73H1700569

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0059-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0059-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-10-31

Product code GEI

K153063Class IIPercuvance Percutaneous Surgical SystemTeleflexmedical, Inc. / cleared 2016-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)