Z-1800-2024Class II

Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model...

Name: Z-1800-2024 Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model...
Creator: Medtronic Perfusion Systems
Published: 2024-03-19
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2024-03-19 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of 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... on 2024-03-19. FDA classified it as Class II and gives the reason as "Potential for unsealed sterile packing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1800-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-19
Posted: 2024-05-10
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
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Potential for unsealed sterile packing.
Root cause tag: manufacturing process
FDA 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 in commerce: 2622 units
Distribution: Worldwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1800-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1793-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1794-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1795-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1796-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1797-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1798-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1799-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1800-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1801-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1802-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1803-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1804-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1805-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10

Product code DWF

K182586Class IIDLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure PortMedtronic, Inc. / cleared 2018-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)