Medtronic DLP Femoral Arterial Cannula — Class II medical device recall Z-1914-2015
Terminated recall by Medtronic Perfusion Systems, reported 2015-07-08, distributed in AK, AZ, CA, CO, IN, KS, LA, MN…. Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the
| Recall number | Z-1914-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2015-06-12 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2016-03-09 |
| Distributed | AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, WI |
| Countries outside the US | BE, BR, CA, CH, CO, DE, DK, ES, FR, GB, GR, HU, IE, IN, IT, KR, MA, NL, PL, QA, SA, SK, TR |
| Quantity | 1,304 devices |
| Lot numbers | 2014124994, 2014125438, 2015016150, 2015016317, 2015016410, 2015016695, 2015016729, 2015017102, 201501C886, 2015020381, 2015020566, 2015021134, 2015021260, 2015021401, 2015021484, 2015030166, 2015030435, 2015030499, 2015030629, 201503C101 |
| Model numbers | 57414, 57417, 57421, 96017, 96021 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.