FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, an FDA Class II recall involving a risk of significant injury (components entering the patient's cavity) corresponds to a severity score of 4 (Severe).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 5,364 units of the Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm, manufactured by Covidien LP. The product is intended for use in gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
The recall was initiated because seals on the device may disengage from the cannula. This failure may result in a component inadvertently disengaging into the patient's cavity. The affected lot numbers range from N2J0211X through N3D0118X. Specific lot numbers N2H0045X, N2H0166X, N2H0286X, N2H0357X, and N2H0516UX are not affected and are acceptable for use.
The affected devices were distributed nationwide in the United States and internationally to numerous countries, including Canada, the United Kingdom, Germany, and Japan. Healthcare providers and facilities should stop using the affected units and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C 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 e
- Manufacturer
- Covidien LP
- Affected units
- 5,364
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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