The Recall Desk
HighFDA (Devices)·Z-0998-2014·Announced 2014-02-26

Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting

Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.

What this means for you

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 is classified as FDA Class II. The hazard involves a structural defect (body splitting) in a medical device used during surgery, which poses a risk of harm, but the source does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported or is theoretical.

Plain-English summary

Medtronic Inc. is recalling all models of its Select 3D and Select CAP Arterial Cannula product families. The recall is due to reports that the cannula body may split near the suture collar. The affected products include Vented models 78818, 78820, and 78822, as well as Non-Vented models 78920, 78922, and 78924. These cannulae are intended for use in perfusion of the ascending aorta during short-term cardiopulmonary bypass.

The recall covers 19,483 units, with 7,669 distributed in the United States and 11,814 distributed internationally. Distribution included the US (nationwide including Puerto Rico) and numerous countries worldwide. Specific lot numbers for each model are listed in the official recall documentation.

Healthcare providers and facilities should stop using these devices and contact Medtronic for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or
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 78818
  • Lot Numbers: 2011021826
  • 2011070534
  • 2011090245
  • 2011110207
  • 2011111844. Model 78820
  • Lot Numbers: 2011062305
  • 2011072337. Model 78822
  • Lot Number: 2011011178 Model 78920
  • Lot Numbers: 2011050717
  • 2011082464
  • 2011120308
  • 2012070891
  • 2012071268
  • 2013081135
  • 2013121551
  • 201106C038. Model 78922
  • Lot Numbers: 2011011187
  • 2011020121
  • 2011020785

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 →

Related recalls

Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management

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Same hazard · structural defect

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