Z-1914-2015 Class II Terminated
Recalled by Medtronic Perfusion Systems
— Brooklyn Park, MN
FDA device recall Z-1914-2015 was initiated by Medtronic Perfusion Systems on Jun 12, 2015 and is designated Class II. 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. The recall status is terminated (terminated Mar 9, 2016). Affected quantity: 1304 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 8, 2015
- Initiation Date
- Jun 12, 2015
- Termination Date
- Mar 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1304 devices
Product Description
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.
Distribution Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1914-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.