Recall Z-1876-2013— Medtronic Inc. Cardiac Rhythm Disease Management
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2013-07-08, terminated 2014-03-06. It names one FDA 510(k) clearance: K791963. Product: Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.. Reason: 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.
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-08
- Terminated
- 2014-03-06
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 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
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