Z-0754-2019Class II

Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is...

Name: Z-0754-2019 Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is...
Creator: Teleflex Medical
Published: 2018-01-03
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2018-01-03 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft... on 2018-01-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0754-2019
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Posted: 2019-01-18
Terminated: 2020-10-30
Recalling firm: Teleflex Medical
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Teleflex, sent an "Urgent Medical Device Recall" letter dated 1/3/2019 to its customers on 01/03/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1.If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected] or hand it to your sales representative. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 1962 units
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.
Product codes and lots: Batch/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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0754-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0753-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-18
Z-0754-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-18

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)