The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1000-2014·Announced 2014-02-26

Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to 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 is classified as FDA Class II and involves a structural defect in a medical device used during cardiopulmonary bypass, which poses a significant risk of injury or harm to patients.

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 are the Medtronic Intersept Custom Tubing Pack, which contains Select 3D or Select CAP Arterial Cannulae. These products are indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures. The recall includes specific models and lot numbers, including Model 3Y90R3 and Model C300901B.

The products were distributed worldwide, including in the United States (nationwide, including Puerto Rico) and internationally to numerous countries. The total quantity involved is 19,483 units, with 7,669 units in the US and 11,814 units outside the US. Healthcare providers and facilities should stop using these products and contact Medtronic for instructions on return or replacement.

The recalled product

Product
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified…
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 (9)

  • Model 3Y90R3
  • Lot numbers: 12227513
  • 12277464
  • 206420618
  • 206618641
  • 206842458
  • 206932996
  • 207184816. Model C300901B
  • Lot number 206499164.

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