Z-2340-2025 Class II Ongoing
FDA device recall Z-2340-2025 was initiated by Boston Scientific Neuromodulation Corporation on July 8, 2025 and is designated Class II. Reason for recall: Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may le… The recall status is ongoing. Affected quantity: 24,583.
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2025
- Initiation Date
- July 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,583
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA, CT, NV, UT, IN, ID, IL, ME, SC, DC, OK, KY, AK, HI, RI, AR, KS, NM and the countries of Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, T¿rkiye, UAE, Ukraine, United Kingdom, Canada, Japan, Argentina, Brazil, Chile, Colombia , Ecuador, Mexico, Hong Kong, China, India, Singapore, Korea, Taiwan.