CLASS II Device recall · Reported 8 Nov 2017 · FDA Enforcement Report
Teleflex(R) Percuvance(TM) Percutaneous Surgical System recalled
Teleflex Medical is recalling Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) Atraumatic, distributed nationwide in the US. The recall was initiated on 18 Oct 2017 and the FDA has classified it as Class II.
Check your package
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-0059-2018
- FDA event ID
- 78340
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2017
- FDA classified
- 31 Oct 2017
- Reported
- 8 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 18 Oct 2017 | Recall initiated by company | |
| 31 Oct 2017 | Classified by FDA | +13 days |
| 8 Nov 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
(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
Where was it sold?
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.
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.
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| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
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| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |