The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0995-2014·Announced 2014-02-26

Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

Medtronic is recalling Select 3D Arterial Cannulae because the device 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device used during cardiopulmonary bypass, which meets the rubric criteria for a structural defect in a high-risk context.

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 that the cannula body may split near the suture collar.

The affected products include Vented models 78618 (18 Fr.) and 78620 (20 Fr.), as well as Non-Vented models 78718 (18 Fr.) and 78720 (20 Fr.). These devices are intended for use in perfusion of the ascending aorta during short-term cardiopulmonary bypass. A total of 19,483 units were distributed, with 7,669 in the United States and 11,814 internationally.

Healthcare providers should stop using the affected devices and contact Medtronic for further instructions. The specific lot numbers for each model are listed in the official recall documentation.

The recalled product

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…
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
Category
Medical Device — Cardiac Surgery
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 78618
  • Lot numbers: 2011041199
  • 2011062306
  • 2011100971
  • 2011102092
  • 2011120307
  • 2012051764
  • 2012061644
  • 2012080274
  • 2012110107
  • 2012120373
  • 2013010071
  • 2013050197
  • 2013081170
  • 2013102358
  • 201203C853. Model 78620
  • Lot numbers: 2011030255
  • 2011040939
  • 2011041341
  • 2011101160 2011111043

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

See all →

Same hazard · structural failure

See all →

Similar recalls