Z-1316-2024Class II

Medtronic DLP Vessel Cannula, Model Number REF 30000

Name: Z-1316-2024 Medtronic DLP Vessel Cannula, Model Number REF 30000
Creator: Medtronic Perfusion Systems
Published: 2024-02-07
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2024-02-07 / Open, Classified / root cause: packaging

FDA source

Medtronic Perfusion Systems began a recall of Medtronic DLP Vessel Cannula, Model Number REF 30000 on 2024-02-07. FDA classified it as Class II and gives the reason as "Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1316-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-07
Posted: 2024-03-19
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic DLP Vessel Cannula, Model Number REF 30000
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Medtronic Cardiac Surgery issued an Urgent: Medical Device Recall to its consignees on 02/07/2024 via UPS. The notice explained the issue, potential risk, and requested consignees identify and quarantine affected product, and arrange to return the affected product by contacting customer service at 1-800-854-3570, option 1, then Option 4. The notification should be shared with others in your organization as appropriate. If product was forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.
Quantity in commerce: 4343 units
Distribution: US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
Product codes and lots: UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1316-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1316-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19

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)