Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2013 - (Recall #: Z-1876-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 8, 2013

Date Posted: August 14, 2013

Recall Number: Z-1876-2013

Event ID: 65757

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

Status: Terminated

Product Quantity: 269

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated