Medtronic Simulus 750 Flexible Ring/Band Accessory Kit Recalled for Tissue Contact
Medtronic CoreValve LLC is recalling six Simulus 750 Flexible Ring/Band Accessory Kits because demonstration units may have contacted non-human tissue.
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 with a risk of harm due to potential contact with non-human tissue, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic CoreValve LLC is recalling six units of the Medtronic Simulus 750 Flexible Ring/Band Accessory Kit. This product is used to size a patient's mitral or tricuspid valve during cardiac procedures. The recall involves demonstration units that were incorrectly sourced to customers.
The recall was initiated because the demonstration products, which are intended for use in wet labs, may have come into contact with non-human (porcine) tissue. This potential contact creates a risk of contamination that is not appropriate for the intended clinical use of the accessory kits.
The affected units were distributed in the United States, specifically in the states of Ohio and Kansas. The specific product code is GTIN: 00643169707535. Healthcare providers and customers who have received these specific demonstration units should stop using them and contact Medtronic CoreValve LLC for further instructions.
The recalled product
- Product
- Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
- Manufacturer
- Medtronic CoreValve LLC
- Affected units
- 6
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 (1)
- GTIN: 00643169707535
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medtronic CoreValve LLC 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 2 products in this recall →Related recalls
Same manufacturer · Medtronic CoreValve LLC
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