Z-0200-2016 Class II Terminated
FDA device recall Z-0200-2016 was initiated by Medtronic Inc. on Sep 29, 2015 and is designated Class II. Reason for recall: 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. The recall status is terminated (terminated Mar 9, 2016). Affected quantity: 64 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 11, 2015
- Initiation Date
- Sep 29, 2015
- Termination Date
- Mar 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 units
Product Description
Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.
Reason for Recall
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Distribution Pattern
Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.
Code Information
Lot U531
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0200-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026