Z-2218-2026Class II

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass...

Name: Z-2218-2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass...
Creator: Medtronic Perfusion Systems
Published: 2026-04-21
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2026-04-21 / Open, Classified / root cause: packaging

FDA source

Medtronic Perfusion Systems began a recall of Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter on 2026-04-21. FDA classified it as Class II and gives the reason as "Certain lots of product have the potential for a sterile barrier breach". 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-2218-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-21
Posted: 2026-05-20
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Certain lots of product have the potential for a sterile barrier breach.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 4/21/2026 via UPS. The notice explained the issue, potential risk. and requested that the affected product be returned by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return for credit or replacement product. Consignees were directed to share this notification with others in your organization as appropriate. If the product listed above has been forwarded to another facility, please notify the facility. For questions regarding this communication, consignees were asked contact their Medtronic representative.
Quantity in commerce: 2620 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
Product codes and lots: GTIN 00643169454736, Lot Numbers: 0231650787, 0231758255, 0231862812, C231966207; GTIN 00673978188713, Lot Numbers: 0231937422; GTIN 20643169454730, Lot Numbers: 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422, C231965721, C231966207, C232428221, C232430086.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2218-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2214-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2215-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2216-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2217-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2218-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2219-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2220-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2221-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20
Z-2222-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-20

Product code DWF

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)