Recall Z-1000-2014— Medtronic Inc. Cardiac Rhythm Disease Management
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: K800178. Product: Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.. 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 recordK-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 Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.
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.