—#208373

Product

The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K101274
Affected lot / code info: UDI-DI: 00607567700406 (VH-4000); 00607567700451 (VH-4001) Lot Numbers; 3000371260 3000378288 3000362934 3000371798 3000378554 3000372477 3000378950 3000376542 3000380314 3000377320 3000380847

Why it was recalled

There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Maquet Cardiovascular, LLC (MCV), a subsidiary of Getinge issued Urgent Medical Device Removal Letter to consignees via FedEx 2-Day Delivery with Signature Proof of Delivery (SPOD) on 31 May 2024. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the HemoPro devices with the product code/lot number(s) listed in this notice. " Prior to use, always refer to Instructions for Use, Section Warning and Precautions , specifically: o HemoPro 2 Always advance the C-Ring and Harvesting Tool under endoscopic visualization. Ensure adequate visualization of the HEMOPRO 2 Jaws and the surgical site prior to application of electrosurgical energy. If visualization of the surgical site is impaired, do not initiate or continue activation of energy to the HEMOPRO 2 Jaws to avoid thermal injury to tissue. o HemoPro: Always advance the C-Ring and Harvesting Tool under endoscopic visualization. CAUTION: Take care to avoid engaging the components of the C-Ring assembly with the VASOVIEW HEMOPRO jaws. Doing so may damage portions of the C-Ring assembly causing the components to separate from the assembly and fall into the body. " Should you have any affected product as listed in this notification, do not use the product and remove it from areas of use. You will receive credit upon the return of any affected devices. " Please forward this information to all current and potential HemoPro and HemoPro 2 users within your hospital / facility. " If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action. " Please contact Getinge Customer Service at 888-880-2874 between 6:00 a.m. and 5:00 p.m. Pacific Standard Time to request a return material authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: NationwideForeign: AT DE DK ES GB HK IT NL ZA

Timeline

Recall initiated: 2024-05-31
Posted by FDA: 2024-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208373. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.