Z-1914-2015Class II

Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement...

Name: Z-1914-2015 Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement...
Creator: Medtronic Perfusion Systems
Published: 2015-06-12
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2015-06-12 / Terminated / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using... on 2015-06-12. FDA classified it as Class II and gives the reason as "Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1914-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Posted: 2015-06-26
Terminated: 2016-03-09
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator components utilize tip indicator bands for minimum tip alignment of the component parts. The cannula body is marked for depth insertion. The components are designed to fit over each other to progressively dilate the vessel during insertion. The dilator allows a 0.1-cm (0.038-in) guidewire to pass through it to aid in insertion. A soft, tapered transition fitting terminates in a 0.95-cm (3/8-in) connection site or barbed connector.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic sent an Urgent Medical Device Recall letter, dated June 2015 to customers beginning June 12, 2015. The letter identified affected product, described the issue, requested that unused inventory be quarantined and returned to Medtronic. Customers should contact Customer Service at 800-854-3570 and reference RADAR #241958 to initiate a return and credit of product. Additionally a Customer Confirmation Certificate should be completed and faxed to 651-367-0612.
Quantity in commerce: 1304 devices
Distribution: Worldwide Distribution - US Distribution including the states of : AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, and WI., and to the countries of : Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Morocco, Netherlands, Poland, Qatar, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.
Product codes and lots: Model 57414 / Lot Numbers: 2014124994, 2015016150, 2015016729, 2015020381, 2015021484, and 201501C886. Model 57417 / Lot Numbers: 2014125438, 2015016317, 2015016695, 2015020566, 2015021401, 2015030166, 2015030435, 2015030629, and 201503C101. Model 57421 / Lot Numbers: 2015016410 and 2015017102. Model 96017 / Lot Numbers: 2015021260 and 2015030499 Model 96021 / Lot Number: 2015021134.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1914-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1914-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26

Product code DWF

K875353Class IIPercutaneous Arterial/venous Cannula Placement KitDlp, Inc. / cleared 1988-03-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)