FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
- Recall number
- Z-1800-2024
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
- Status
- Open, Classified
- Initiated
- 2024-03-19
- Posted
- 2024-05-10
- Terminated
- not on file
- Reason
- Potential for unsealed sterile packing.
- Root cause
- Process control
- Action
- Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
- Quantity
- 2622 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- a) Model Number 24009, GTIN 00673978178646, Lot Numbers: 2023040211, 2023040854, 2023041224; a) Model Number 24009, GTIN 20613994495420, Lot Numbers: 2023031043, 2023031563, 2023040211, 2023040480, 2023040854, 2023040855, 2023041224, 202305C108, 202305C109, 202306C196; b) Model Number 11316, GTIN 20613994676140, Lot Numbers: 2023040437; c) Model Number 11014L, GTIN 20613994495499, Lot Numbers: 2023040807, 2023040808, 202305C076, 202306C138
- 510(k) numbers
- ["K182586"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28