CLASS II Device recall · Reported 30 Jan 2019 · FDA Enforcement Report

Percuvance(R) Percutaneous Shaft recalled by Teleflex Medical

Teleflex Medical is recalling Percuvance(R) Percutaneous Shaft, PCVSHL3 The Percutaneous Surgical System with, distributed nationwide in the US. The recall was initiated on 3 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch/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

Quantity recalled1962 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0754-2019
FDA event ID: 81909
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class II
Status: Terminated
Recall initiated: 3 Jan 2018
FDA classified: 18 Jan 2019
Reported: 30 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

3 Jan 2018	Recall initiated by company
18 Jan 2019	Classified by FDA	+380 days
30 Jan 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 81909

Reported	Class	Recall	Company	Reason	Where
30 Jan 2019	CLASS II	Percuvance(R) Percutaneous Shaft recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	Nationwide

More recalls from Teleflex Medical

All 235

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022Device	CLASS II	Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
1 Jun 2022Device	CLASS II	Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled	Teleflex Medical	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide