Z-1796-2024Class II

Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001

Name: Z-1796-2024 Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
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 I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001 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-1796-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-19
Posted: 2024-05-10
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
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: 7935 units
Distribution: Worldwide distribution.
Product codes and lots: GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1796-2024
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

K810820Class IICardiopulmonary BypassDlp, Inc. / cleared 1981-04-03

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)