Medtronic Mullins Transseptal Catheter Sheath Recall for Labeling Error
Medtronic is recalling specific lots of Mullins Transseptal Catheter Introducer Sheaths because packages labeled as 7F may contain 8F dilators.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling specific lots of the Mullins Transseptal Catheter Introducer Sheath, model 008551. The recall involves 269 units distributed worldwide, including the United States, Australia, Brazil, Chile, India, and Singapore.
The recall is due to a labeling issue where packages identified as 7F (French) may actually contain an 8F (French) dilator. The source text notes that due to the differences in size, an 8F dilator will not fit properly, though the specific consequences are not detailed in the provided text.
Healthcare providers and facilities should check their inventory for the affected lot numbers: 50672012, 50676944, 50683123, 50693426, and 50710622. Medtronic is requesting the return of these potentially mis-labeled devices.
The recalled product
- Product
- Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Hazard
- Affected units
- 269
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers: 50672012
- 50676944
- 50683123
- 50693426
- 50710622.
Distribution
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