Medtronic DPL Single Stage Venous Cannula Recalled for Rough Metal Edges
Medtronic is recalling DPL Single Stage Venous Cannulas used in cardiopulmonary bypass due to potential rough metal edges on the tip side ports.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a physical defect (rough metal edges) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling the DPL Single Stage Venous Cannula with Metal Tip. These devices are used in cardiopulmonary bypass procedures. The recall involves 13,691 units distributed worldwide, including the United States and numerous international locations.
The recall is due to a potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and facilities should identify and stop using the affected model numbers and lot numbers listed in the official recall notice. Consumers are advised to contact their healthcare provider if they have had a procedure involving these specific devices.
The recalled product
- Product
- Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Category
- Medical Device — Cardiac Surgery
Distribution
Distributed nationwide across the United States.
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