Teleflex Percuvance Percutaneous Surgical System Recalled for Tool Tip Breakage

Plain-English summary

Teleflex Medical is recalling specific components of the Teleflex(R) Percuvance(TM) Percutaneous Surgical System. The affected items include 5 mm Atraumatic Johans Graspers, Maryland Dissectors, Hem-o-lok Clip Appliers, Traumatic Gripper Graspers, and Scissors. These instruments are used to perform laparoscopic procedures and are designed to grasp, retract, manipulate, cut, coagulate, and deliver ligating clips to soft tissue.

The recall is being issued because the jaws of the tool tips may break, which could cause a fragment of the tool tip to fall off during use. A total of 3,904 units were distributed worldwide, including nationwide distribution in the United States and to Australia, Belgium, Hong Kong, Japan, South Korea, and Singapore.

Healthcare providers and facilities should stop using the affected instruments immediately. Users should check their inventory against the specific catalog numbers and lot numbers listed in the official recall notice to identify affected units. Teleflex Medical is the recalling firm responsible for managing this safety action.

The recalled product

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, Catalo

Manufacturer

Teleflex Medical

Category

Medical Device — Surgical Instruments

Hazard

• structural-failure
• foreign-object

Affected units

3,904

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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