Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise
Medtronic is recalling 230 Clearify Visualization Systems because the sterile barrier was breached, compromising product sterility. The recall covers worldwide distribution.
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 3/5 (High).
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 involves a medical device where sterility is compromised, creating a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic is recalling 230 units of the Clearify Visualization System (Item Code: 21-345) contained in Best Practices kits. These systems are intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope and clean the scope lens.
The recall was initiated because the product sterility is compromised due to a breach of the sterile barrier. The affected units were distributed worldwide, including in the United States and numerous foreign countries such as Austria, Belgium, Brazil, France, Germany, Japan, and the United Kingdom.
Healthcare providers and consumers should stop using the affected Clearify Visualization Systems immediately. The source text does not specify specific lot numbers or expiration dates, so users should verify their inventory against the kit parent codes listed in the official recall notice to determine if their units are affected.
The recalled product
- Product
- Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
- Manufacturer
- Medtronic
- Affected units
- 230
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medtronic 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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