Recall Z-0200-2016— Medtronic Inc.

Name: FDA recall Z-0200-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-29

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc., initiated 2015-09-29, terminated 2016-03-09. It names one FDA 510(k) clearance: K102588. 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.. Reason: 64 units of Achieve Electrical Cables were shipped with a potential sterility breach..

Recalling firm: Medtronic Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-09-29
Terminated: 2016-03-09
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K102588 — ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLEMedtronic Ablation Frontiers, LLC·cleared 2011-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.