Z-2402-2021 Class I Ongoing
FDA device recall Z-2402-2021 was initiated by Micro Therapeutics Inc, on July 13, 2021 and is designated Class I. Reason for recall: Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. The recall status is ongoing. Affected quantity: 16,169 total devices for all model/products.
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- July 13, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,169 total devices for all model/products
Product Description
Reason for Recall
Distribution Pattern
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Macedonia, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Brunei Darussalam, Egypt, Israel, Jordan, Lebanon, Qatar, Saudi Arabia, Syrian Arab Republic, United Arab Emirates, South Africa, Tunisia, Reunion, China, Hong Kong, Macao, Singapore, Taiwan, Australia, New Zealand, Bangladesh, India, Pakistan, Indonesia, Malaysia, Thailand, Vietnam, Japan, and Republic of Korea.