Z-1191-2013 Class I Terminated
FDA device recall Z-1191-2013 was initiated by Medtronic Neuromodulation on Feb 8, 2013 and is designated Class I. Reason for recall: There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when… The recall status is terminated (terminated May 22, 2014). Affected quantity: 30,000.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2013
- Initiation Date
- Feb 8, 2013
- Termination Date
- May 22, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,000
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam.
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-1191-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026