The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0999-2014·Announced 2014-02-26

Medtronic Recalls Select 3D and CAP 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 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 aligns with the rubric criterion for structural defects in high-risk medical contexts.

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 being conducted due to reports of the cannula body splitting near the suture collar.

These cannulae are intended for use in perfusion of the ascending aorta during short-term cardiopulmonary bypass. The affected products include non-vented, Carmeda-coated models sterilized using ethylene oxide. The recall covers 19,483 total units, with 7,669 distributed in the United States and 11,814 distributed internationally.

The products were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as to numerous international locations. Specific lot numbers involved in the recall include 12259014, 206292900, 12011874, 12286525, 12086013, 06867511, and 206784461. Healthcare providers and facilities should stop using these devices and contact Medtronic for further instructions.

The recalled product

Product
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of…
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 (7)

  • Lot numbers: 12259014
  • 206292900
  • 12011874
  • 12286525
  • 12086013
  • 06867511
  • 206784461.

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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