Agency classClass IIOur severity:Severe FDA (Devices)·Z-1467-2013·Announced 2013-06-12

FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk

The FDA is recalling 2,716 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a component disengaging into the patient's cavity, which constitutes a significant injury risk.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 2,716 units of the Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long (Product Code: ONB5LGF), manufactured by Covidien LP. The recall is due to a defect where seals may disengage from the cannula, which may result in a component inadvertently disengaging into the patient's cavity.

The affected devices are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry. The recall covers lot numbers N2H0414X through N3A0294X, with the specific exception of lot numbers N2H0045X, N2H0166X, N2H0286X, N2H0357X, and N2H0516UX, which are not affected and are acceptable for use.

The affected products were distributed worldwide, including nationwide in the United States and internationally to countries such as Canada, Austria, Bahrain, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement.

The recalled product

Product: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of…
Manufacturer: Covidien LP
Category: Medical Device — Surgical Instruments
Hazard: component-disengagement
foreign-body
Affected units: 2,716

Is your product affected?

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

Lot numbers (4)

N2H0166X
N2H0286X
N2H0357X
N2 H051 6UX

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Covidien LP

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Same hazard · component disengagement