Z-2340-2025 Class II Ongoing
FDA device recall Z-2340-2025 was initiated by Boston Scientific Neuromodulation Corporation on Jul 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… The recall status is ongoing. Affected quantity: 24,583.
Recall details
- Product Type
- Devices
- Report Date
- Aug 27, 2025
- Initiation Date
- Jul 8, 2025
- 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.
Code information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2340-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026