FDA Device recall Z-1914-2015
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021 by Medtronic Perfusion Systems, citing 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 perfu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1914-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-12 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, WI |
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
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.
Identifiers
| code_info | Model 57414 / Lot Numbers: 2014124994, 2015016150, 2015016729, 2015020381, 2015021484, and 201501C886. Model 574…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1914-2015%22
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