Medtronic Simulus 850 Sizer Kits Recalled Due to Porcine Tissue Contact
Medtronic is recalling six Simulus 850 Semi Rigid Ring/Band Accessory Kits because demonstration units may have contacted porcine 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 exposure to non-human tissue, which is a high-risk hazard where injury has not yet been reported, fitting the criteria for a score of 3.
Plain-English summary
Medtronic CoreValve LLC is recalling six units of the Simulus 850 Semi Rigid Ring/Band Accessory Kit. These kits are used to size a patient's mitral or tricuspid valve during cardiac procedures.
The recall was initiated because demonstration Simulus Reusable Sizer Accessory Kits were incorrectly sourced to customers. The demonstration products, which are intended for use in wet labs, may have come into contact with non-human (porcine) tissue.
The affected units were distributed in Ohio and Kansas. Customers who received these kits should stop using them and contact Medtronic CoreValve LLC for instructions on return or replacement.
The recalled product
- Product
- Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit 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: 00643169707573
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
See all →- HighMedtronic Simulus 750 Flexible Ring/Band Accessory Kit Recalled for Tissue Contact
FDA (Devices) · 2020-03-18
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