Z-0995-2014Class II

Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae...

Name: Z-0995-2014 Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2014-01-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-01-30 / Terminated

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of 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.)... on 2014-01-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0995-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-30
Posted: 2014-02-20
Terminated: 2014-10-06
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, 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.
FDA root cause: Under Investigation by firm
Action: The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated January, 2014 via UPS on January 30, 2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all listed product in your inventory; return all listed product to Medtronic and contact Customer Service at 800 854-3570 and reference RADAR #167826 to initiate a return and credit of product; complete and return the attached Customer Confirmation Certificate via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality, and share this notification with others in your organization as appropriate. Select 3D and Select CAP Arterial Cannula are not available for purchase at this time. Please contact your Medtronic sales representative or Medtronic LifeLine Technical Services at 1 877-526-7890 or (+1 763) 526-7890 to assist with alternative cannula selection and any additional questions you may have related to this notification.
Quantity in commerce: 19483 total (7669 US, 11814 OUS)
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0995-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19
Z-0996-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19
Z-0997-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19
Z-0998-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19
Z-0999-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19
Z-1000-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19

Product code DWF

K043179Class IISelect 3D Arterial CannulaMedtronic Perfusion Systems / cleared 2005-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)