The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0996-2014·Announced 2014-02-26

Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (body splitting) that poses a risk of harm during a critical procedure, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Inc. Cardiac Rhythm Disease Management is recalling all models of its Select 3D and Select CAP Arterial Cannula product families. The recall is due to reports of the cannula body splitting near the suture collar.

The affected products include the Select 3D Arterial Cannulae, specifically the Vented model 78622 (22 Fr.) and Non-Vented model 78722 (22 Fr.). These devices are intended for use in perfusion of the ascending aorta during short-term cardiopulmonary bypass. The recall covers 19,483 units distributed worldwide, including the United States and numerous international markets.

Healthcare providers and facilities should stop using the affected cannulae and contact Medtronic for instructions on how to return or dispose of the devices. Patients who have had these devices used during surgery should contact their healthcare provider if they have concerns.

The recalled product

Product
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…
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
Category
Medical Device — Cardiovascular
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model 78622
  • Lot numbers: 2011031714
  • 2011040345
  • 2011050373
  • 2011060471
  • 2011060641
  • 2011060642
  • 2011070099
  • 2011072408
  • 2011081502
  • 2011102965
  • 2011111215
  • 2011120575
  • 2012011143
  • 2012011425
  • 2012020052
  • 2012040536
  • 2012051387
  • 2012090216
  • 2012101333

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Medtronic Inc. Cardiac Rhythm Disease Management under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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