Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a potential sterility compromise in a surgical device, which poses a significant risk of infection or injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System, part number VSP550. The recall is due to the possibility that the sterility of the medical devices may be compromised.
The affected units are sterile, prescription-only devices indicated for use in minimally invasive surgery to allow access for vessel harvesting, primarily for patients undergoing endoscopic surgery for arterial bypass. The specific lot numbers involved are 21K, 31K, 32K, 33K, 34K, and 35K.
Distribution was nationwide in the United States, specifically in the states of Louisiana, New Jersey, and New York. Healthcare providers and facilities should stop using the affected units and contact Terumo for further instructions.
The recalled product
- Product
- VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 26
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 (6)
- Lot numbers: 21K
- 31K
- 32K
- 33K
- 34K
- 35K
Distribution
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