FDA-Device2021-09-29Class II
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Medtronic Perfusion Systems
Hazard
Potential for a wire protrusion through the left heart vent catheter tip
Sold states
Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, Yemen.
Affected count
51,494 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2504-2021Don't want to check this manually?
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