Medtronic Achieve Cables, model 990066. The sterile… recallZ-0200-2016 · Medtronic Inc. · initiated Sep 29, 2015
Class II Terminated All recalls posted in November 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-0200-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 29, 2015
- Posted by the FDA
- Nov 2, 2015
- Recalling firm
- Medtronic Inc.
- Quantity
- 64 units
- Product code
- DRF
- FDA submissions
- K102588
- 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.
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.
Code information (models, lots, serial numbers)
Lot U531
Other devices under the same FDA submission
2 devices cleared under K102588 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ACHIEVE™ 990063-020Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING7 deaths129 reports
- ACHIEVE™ 990063-015Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths27 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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