Recall Z-0995-2014— Medtronic Inc. Cardiac Rhythm Disease Management

Name: FDA recall Z-0995-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-30

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2014-01-30, terminated 2014-10-06. It names one FDA 510(k) clearance: K043179. 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.. Reason: 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..

Recalling firm: Medtronic Inc. Cardiac Rhythm Disease Management
Classification: Class II
Status: Terminated
Initiated: 2014-01-30
Terminated: 2014-10-06
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K043179 — SELECT 3D ARTERIAL CANNULAMedtronic Perfusion Systems·cleared 2005-02-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.