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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a component potentially entering the patient's cavity, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Versaport Bladeless Optical Fixation Cannula - 5mm Short (Product Code: ONBFCA5SH) manufactured by Covidien LP. The recall involves 2,705 units that were distributed nationwide in the United States and internationally to multiple countries, including Canada, the United Kingdom, Germany, and Japan.
The recall was initiated because seals on the cannula may disengage. This defect may result in a component inadvertently disengaging and entering the patient's cavity. The product is intended for use in gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
The affected lot numbers range from N2J0315X through N3A0389X. However, the following specific lot numbers are not affected by this recall and are acceptable for use: N2H0045X, N2H0166X, N2H0286X, N2H0357X, and N2H0516UX. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH 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
- Affected units
- 2,705
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.
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