Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, mode...
FDA Device Recall #Z-0997-2014 — Class II — January 30, 2014
Recall Summary
| Recall Number | Z-0997-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 30, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 19483 total (7669 US, 11814 OUS) |
Product Description
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Reason for Recall
Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
Distribution Pattern
Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.
Lot / Code Information
Model 78624, Lot numbers: 2011010432, 2011010514, 2011010515, 2011011141, 2011011543, 2011021907, 2011040344, 2011040946, 2011060613, 2011060865, 2011070535, 2011071749, 2011081635, 2011110330, 2011120304, 2011120305, 2011121133, 2012060424, 2012060431, 2012070886, 2012080324, 2012081353, 2012081928, 2012090013, 2012120521, 2012121021, 2012121414, 2013031142, 2013050555, 2013050805, 2013051225, 2013051640, 2013060249, 2013090499, 2013090570, 2013091332, 2013091924, 201106C140, 201203C844, 201310C579. Model 78724, Lot numbers: 2011032145, 2011050718, 2011060852, 2011092067, 2011102225, 2012032345, 2012071614, 2012081704, 2012081973, 2013031364, 2013051818, 2013060581, 2013070831, 2013080858, 2013100654, 2013110548, 2014010275, 201108C228, 201203C842.
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| Z-0022-2016 | Class II | Medtronic Medical Device Identification Card fo... | Sep 15, 2015 |
| Z-2777-2015 | Class II | Medtronic CryoConsole, models 106A3, 106E2, and... | Sep 1, 2015 |
| Z-1365-2015 | Class II | Covidien Trellis 6 and Trellis 8 Peripheral Inf... | Mar 23, 2015 |
| Z-1356-2015 | Class II | Medtronic Dual Chamber Temporary External Pacem... | Mar 17, 2015 |
| Z-1276-2015 | Class I | Medtronic, 10 Fr FlexCath Select Steerable Shea... | Feb 23, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.