CLASS II Device recall · Reported 26 Feb 2014 · FDA Enforcement Report
Medtronic Select 3D Arterial Cannulae recalled
Medtronic Inc. Cardiac Rhythm Disease Management is recalling Medtronic Select 3D Arterial Cannulae, distributed nationwide in the US. The recall was initiated on 30 Jan 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0996-2014
- FDA event ID
- 67400
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jan 2014
- FDA classified
- 19 Feb 2014
- Reported
- 26 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 30 Jan 2014 | Recall initiated by company | |
| 19 Feb 2014 | Classified by FDA | +20 days |
| 26 Feb 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model 78622, Lot numbers: 2011031714, 2011040345, 2011050373, 2011060471, 2011060641, 2011060642, 2011070099, 2011072408, 2011081502, 2011102965, 2011111215, 2011120575, 2012011143, 2012011425, 2012020052, 2012040536, 2012051387, 2012090216, 2012101333 ,2013010957, 2013011791, 2013020303, 2013030729, 2013040209, 2013040282, 2013040710, 2013041272, 2013051447, 2013060736, 2013071836, 2013072009, 201105C105, 201203C854. Model 78722, Lot numbers: 2011031588, 2011031885, 2011051006, 2011051226, 2011061585, 2011071672, 2011082216, 2011091825 , 2011101670, 2011102093, 2011110717, 2011120059, 2012060478, 2012061056, 2012061057, 2012061725, 2012070570, 2012090657, 2013011121, 2013021260, 2013030685, 2013040494, 2013040595, 2013070162, 2013070483, 2013081289, 2013081603, 201108C227.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 67400This product is part of a recall event; the main page for the event is Medtronic Select CAP Arterial Cannulae recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medtronic Select CAP Arterial Cannulae recalled | Medtronic Inc. Cardiac Rhythm Disease Management | Other | Nationwide | |
| CLASS II | Medtronic Select 3D Arterial Cannulae recalled | Medtronic Inc. Cardiac Rhythm Disease Management | Other | Nationwide | |
| CLASS II | Medtronic Select 3D Arterial Cannulae recalled | Medtronic Inc. Cardiac Rhythm Disease Management | Foreign Material | Nationwide | |
| CLASS II | Medtronic Intersept Custom Tubing Pack which contain Select recalled | Medtronic Inc. Cardiac Rhythm Disease Management | Other | Nationwide | |
| CLASS II | Medtronic Select CAP Arterial Cannulae recalled | Medtronic Inc. Cardiac Rhythm Disease Management | Foreign Material | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |