Medtronic Perfusion Systems: 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.

Recall number

Z-1914-2015

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.

Status

Terminated

Initiated

2015-06-12

Posted

2015-06-26

Terminated

2016-03-09

Reason

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

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K875353"]

PMA numbers

not on file

Product code

DWF

Firm FEI

1000116158

Firm city

Brooklyn Park

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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