Medtronic Select 3D Arterial Cannulae
Medical device recall Z-0995-2014. Published in FDA’s Enforcement Report on Feb 26, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 26, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 19483 total (7669 US, 11814 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8” (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5” (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
19483 total (7669 US, 11814 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 78618, Lot numbers: 2011041199, 2011062306, 2011100971, 2011102092, 2011120307, 2012051764, 2012061644, 2012080274, 2012110107, 2012120373, 2013010071, 2013050197, 2013081170, 2013102358, 201203C853. Model 78620, Lot numbers:…
Every code shown here, 1,110 characters
Model 78618, Lot numbers: 2011041199, 2011062306, 2011100971, 2011102092, 2011120307, 2012051764, 2012061644, 2012080274, 2012110107, 2012120373, 2013010071, 2013050197, 2013081170, 2013102358, 201203C853. Model 78620, Lot numbers: 2011030255, 2011040939, 2011041341, 2011101160 2011111043, 2012011041, 2012020540, 2012070617, 2012110017, 2012111257, 2013031297, 2013050408, 2013060024, 2013060816, 2013070896, 2013090420, 2013091570, 2013101359. Model 78718, Lot numbers: 2011020219, 2011051461, 2011051501, 2011060279, 2011081265, 2011091551, 2011100022, 2011111305, 2012011048, 2012032171, 2012040645, 2012070832, 2012071313, 2013031493, 2013041737, 2013051367, 2013060409, 2013091960, 2013102157, 2013110588, 201110C116, 201203C855. Model 78720, Lot numbers: 2011010067, 2011021825, 2011062606, 2011062607, 2011070536, 2011071117, 2011080605, 2011081029, 2011081501, 2011082463, 2011090046, 2011090047, 2011100092, 2012011142, 2012011424, 2012051863, 2012060210, 2012061344, 2012061868, 2012120133, 2012120781, 2012120941, 2012121072, 2013030331, 2013030943, 2013080633, 2013081206, 2013110894, 2013120553.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 30, 2014.
- FDA classified it on Feb 19, 2014.
- FDA’s Enforcement Report published it on Feb 26, 2014.
- FDA terminated it on Oct 6, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc. Cardiac Rhythm Disease Management, of Saint Paul, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.