Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1876-2013

Z-1876-2013 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

FDA device recall Z-1876-2013 was initiated by Medtronic Inc. Cardiac Rhythm Disease Management on July 8, 2013 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated March 6, 2014). Affected quantity: 269.

Recall Details

Product Type: Devices
Report Date: August 14, 2013
Initiation Date: July 8, 2013
Termination Date: March 6, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 269

Product Description

Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.

Reason for Recall

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

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.

Code Information

Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.

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