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FDA · Medical device recall

Vasoview 6 Pro (VV6)…

Recall started · FDA enforcement report Nov. 8, 2023 Class II

Reason
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Status
Ongoing
Distribution
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.

This box checks this one record only. Other recalls of the same product or company are on the brand page.

Enforcement report date
Nov. 8, 2023
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): 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)
Status
Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
Maquet Cardiovascular, LLC
Product
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Reason
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
Distribution pattern
US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
Quantity
N/A
Codes and lots
UDI-DI: 00607567700239, Lot: 3000313857.
Recall started
Sept. 19, 2023
Voluntary or mandated
Voluntary: Firm initiated
Device type
Electrosurgical, Cutting & Coagulation & Accessories
Root cause (FDA)
Under Investigation by firm
What the company told customers
An Urgent Medical Device Removal notice was sent October 06, 2023 advising customers examine inventory, stop using, and remove any affected product from areas of use and return it to Getinge through Customer Service (888) 880-2874 between 6:00AM - 5:00PM PST. The notification should be forwarded to any system users and to any customers to which product was further distributed to. Complete and return the acknowledgement form to VV6proPkg2023.act@getinge.com or fax to (866) 326-9165.
Recall number
Z-0210-2024

What the record says about this device

A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.

Four steps: a device or a product, the reason the record gives, the record's wordsA simplified drawing for a device record; the mark follows the reason the record gives, not a photograph of the product. Left, for comparison: the same drawing without what the record names. Right: this record.1 The record: Vasoview 6 Pro (VV6) - Endoscopic…2 The record describes a label or a document that is wrong3 What the record says4 What the record listsFOR COMPARISONthe same drawing, withoutwhat the record namesTHIS RECORDwhat the record names,step by stepartwork

“Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.”Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2)., FDA enforcement report, 2023-11-08. The caption is the record's own words.

A generic device, not the product. The mark follows the record's own words.

If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.

FDA device name: Electrosurgical, Cutting & Coagulation & Accessories

Distributed in (FDA's record): Alabama Arkansas California Florida Georgia Indiana Kentucky Michigan New Jersey Oklahoma Pennsylvania Tennessee Texas

This recall among the others

  • FDA's enforcement report came 50 days after the firm started the recall. For half of the 835 FDA medical device recall events reported in 2023 with a start date, it took 51 days or fewer (by year).
  • Maquet Cardiovascular: 9 other recalls or notices on this site in the three years before this one (from Nov. 8, 2020).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-0210-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-0210-2024, Nov. 8, 2023. "Vasoview 6 Pro (VV6)." PlainRecords, https://plainrecords.com/recall/device/z-0210-2024/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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