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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65757
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Inc. Cardiac Rhythm Disease Management
City Saint Paul
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart. Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622. Class II Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not fit into a 7F sheath, making any mis-labeled introducer components unusable in a clinical case. 269 Z-1876-2013