Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
FDA device recall Z-0289-2025 · posted 2024-11-04 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
- Action taken
- Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 10/03/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested the affected product be quarantined pending return. The notice is to be shared with all individuals with each facility as appropriate, and the notice distributed to all facilities to which the affected devices was shipped. Contact the local Medtronic Field Representative for questions.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DWF
- Quantity affected
- 420 units
- Distribution
- US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
- Date initiated
- 2024-10-03
- Date posted
- 2024-11-04
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AORTIC ROOT CANNULA (K790565) | Dlp, Inc. | 1979-06-11 |