FDA recall Z-1718-2020

Product

Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds

Reason for recall

Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)

Distribution

Nationwide Foreign:

Key facts

Status

Terminated

Initiation date

2020-03-11

Report date

2020-04-22

Termination date

2022-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonbridge, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1718-2020