The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng

FDA device recall Z-2337-2024 · posted 2024-07-11 · Open, Classified

Recall details

Recalling firm

Maquet Cardiovascular, LLC

Reason for recall

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

600 units

Distribution

NationwideForeign: AT DE DK ES GB HK IT NL ZA

Date initiated

2024-05-31

Date posted

2024-07-11

Location

Wayne, NJ

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