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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc. Cardiac Rhythm Disease Management
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0996-2014
Related Recalls
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
Medtronic Inc. Cardiac Rhythm Disease Management
Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Medtronic Inc. Cardiac Rhythm Disease Management
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.