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Medtronic Neurosurgery recalls Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus
Recalled January 6, 2021 · FDA recall Z-0739-2021 · Medtronic Neurosurgery
Hazard
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention. · FDA Class II
Units
1,926 units
Sold at
Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam
Description
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
Product
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Manufacturer(s)
Medtronic Neurosurgery
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →