Z-0730-2021 Class I Terminated
FDA device recall Z-0730-2021 was initiated by Boston Scientific Corporation on November 17, 2020 and is designated Class I. Reason for recall: Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. The recall status is terminated (terminated January 24, 2022). Affected quantity: 302 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- November 17, 2020
- Termination Date
- January 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 302 devices
Product Description
Reason for Recall
Distribution Pattern
Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.