Agency classClass IIOur severity:Severe FDA (Devices)·Z-1472-2013·Announced 2013-06-12

FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement

The FDA is recalling Versaport Bladeless Optical Fixation Cannulas 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 entering 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 the Versaport Bladeless Optical Fixation Cannula - 5mm (Product Code: ONBFCA5ST) manufactured by Covidien LP. The recall involves 57,461 units distributed worldwide, including the United States and various international markets. The specific lot numbers affected range from N2J0150X through N3C0683X, with the exception of specific lots identified as acceptable for use.

The recall is being conducted because seals on the cannula may disengage. This failure may result in a component inadvertently disengaging and entering the patient's cavity during gynecologic, general, thoracic, or urologic endoscopic procedures. The product is intended to create and maintain a port of entry for these medical procedures.

Healthcare providers and facilities should stop using the affected units and contact the recalling firm for instructions on how to return or dispose of the product. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns.

The recalled product

Product: Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST 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 entry.
Manufacturer: Covidien LP
Category: Medical Device — Surgical Instruments
Hazard: component-disengagement
foreign-body
Affected units: 57,461

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