Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Mullins Transseptal Adult 7F Recalled by Medtronic Inc. Cardiac Rhythm Disease Management Due to Medtronic identified a specific labeling issue for specific...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. Cardiac Rhythm Disease Management directly.
Affected Products
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Quantity: 269
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Inc. Cardiac Rhythm Disease Management has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report