Z-0984-2025Class II

DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

Name: Z-0984-2025 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Creator: Medtronic Perfusion Systems
Published: 2024-12-12
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2024-12-12 / Open, Classified / root cause: packaging

FDA source

Medtronic Perfusion Systems began a recall of DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) on 2024-12-12. FDA classified it as Class II and gives the reason as "Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae". 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-0984-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-12
Posted: 2025-01-17
Recalling firm: Medtronic Perfusion Systems
Product: DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Root cause tag: packaging
FDA root cause: Packaging
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 12/12/24 was sent to customers. Patient Recommendations: Patients previously supported with an impacted device face no additional risk from the issue described in this communication and should continue to be monitored per your practice s normal follow-up procedures. Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " Return unused, listed product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. " Complete the enclosed Customer Confirmation Form and email to [email protected]. This form must be returned even if you do not have any affected product in your possession. " Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this . " Please maintain a copy of this communication in your records. If you have any questions regarding this communication, please contact your Medtronic Field Representative.
Quantity in commerce: 745 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0984-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0984-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0985-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0986-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17

Product code DWF

K024069Class IIOne Piece Pediatric Arterial Cannula, Model: 77006, 77106Medtronic Vascular / cleared 2003-01-08

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)