Z-0200-2016Class II

Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides...

Name: Z-0200-2016 Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides...
Creator: Medtronic Inc.
Published: 2015-09-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-09-29 / Terminated / root cause: sterility

FDA source

Medtronic Inc. began a recall of Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of... on 2015-09-29. FDA classified it as Class II and gives the reason as "64 units of Achieve Electrical Cables were shipped with a potential sterility breach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0200-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-29
Posted: 2015-11-02
Terminated: 2016-03-09
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: 64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 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.
Product codes and lots: Lot U531

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0200-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0200-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-02

Product code DRF

K102588Class IIAchieve Mapping Catheter and Electrical CableMedtronic Ablation Frontiers, LLC / cleared 2011-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)