Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduc
FDA device recall Z-0200-2016 · posted 2015-11-02 · Terminated
Recall details
- Recalling firm
- Medtronic Inc.
- Reason for recall
- 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
- Action taken
- Medtronic sales reps began notifying customers on 9/29/2015. Customers were told of the issue and were requested to quarantine and return un-used product. A follow-up Urgent Medical Device Recall letter was hand delivered beginning 10/6/2015. The letter again described the issue, identified affected product and asked that un-used product be returned to Medtronic. A response form was asked to be returned to Medtronic. Customer with questions can contact Medtronic AF Solutions at 888-843-8301
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 64 units
- Distribution
- Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.
- Date initiated
- 2015-09-29
- Date posted
- 2015-11-02
- Date terminated
- 2016-03-09
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE (K102588) | Medtronic Ablation Frontiers, LLC | 2011-03-18 |