Terumo recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System (VSP550EX) due to a generator compatibility issue that could affect surgical safety. Affected units may require specific generator checks.
The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU.
Terumo is recalling its VirtuoSaph Plus Endoscopic Vessel Harvesting System (VSP550EX) because recent reports show one generator model is not compatible with the system. This could lead to surgical complications if the incorrect generator is used during procedures.
The system's instructions list compatible generators, but recent reports indicate one specific generator model is not compatible. Using this incompatible generator could cause surgical complications during vessel harvesting procedures.
Surgical teams using the VirtuoSaph Plus system for endoscopic vessel harvesting procedures are most at risk. Patients undergoing arterial bypass grafting surgeries may be affected if the system is used with an incompatible generator.
Check for the catalog number VSP550EX on the device. The product was sold with lot number 81K. This recall applies to the VirtuoSaph Plus Endoscopic Vessel Harvesting System used in minimally invasive surgery.
Verify that the generator used with the system is listed as compatible in the instructions for use (IFU).
The recall is due to recent reports that one generator model is not compatible with the VirtuoSaph Plus system, which could lead to surgical complications.
Check the generator compatibility with the system's instructions for use (IFU) to ensure it is listed as compatible.
The official recall notice does not specify a deadline for checking generator compatibility.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-0227-2019 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-0227-2019 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
