Z-2137-2013 Class II Terminated
FDA device recall Z-2137-2013 was initiated by Boston Scientific Corporation on Jul 31, 2013 and is designated Class II. Reason for recall: Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon… The recall status is terminated (terminated Jan 27, 2015). Affected quantity: 1,331.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 11, 2013
- Initiation Date
- Jul 31, 2013
- Termination Date
- Jan 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,331
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Sweden, Austria, Germany, Netherlands, Switzerland, Belgium, Great Britain, Norway, Taiwan, Brazil, Greece, Panama, Turkey, Canada, Hong Kong, Poland, Unit.Arab Emir., China, India, Russian Fed., Colombia, Ireland, Saudi Arabia, Czech Republic, Israel, South Africa, Denmark, Italy, and South Korea.
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-2137-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026