Z-1876-2013Class II

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

Name: Z-1876-2013 Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2013-07-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-07-08 / Terminated / root cause: packaging

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart on 2013-07-08. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1876-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Posted: 2013-08-05
Terminated: 2014-03-06
Recalling firm: Medtronic, Inc.
Product: Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Product code: DYB Introducer, Catheter
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
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Consignees were sent on 7/8/2013 a Medtronic, Inc " Urgent Medical Device Recall" letter dated 8 July 2013. The letter was addressed to Healthcare Professionals. The letter identified the problem and the product involved in the recall. Advised consignees to remove and quarantine the product from their inventory and return the product. Requested consignees to complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. If the product has been further distributed advised consignees to please notify them of the recall.
Quantity in commerce: 269
Distribution: 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 codes and lots: Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1876-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1876-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05

Product code DYB

K791963Class IIUsci Mullins Transseptal Catheter Intro.C.R. Bard, Inc. / cleared 1979-11-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)