Recall – ICD fails to process collected data

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 12/1/2021
Class II


Medtronic CareLink SmartSync Device Manager application software (D00U005) used by Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds):

  • Cobalt XT VR: DVPA2D1, DVPA2D4;
  • Cobalt VR: DVPB3D1, DVPB3D4;
  • Cobalt XT DR: DDPA2D1, DPA2D4;
  • Cobalt DR: DDPB3D1, DDPB3D4;
  • Cobalt XT HF: DTPA2D4, DTPA2D1;
  • Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1;
  • Cobalt HF: DTPB2D4, DTPB2D1;
  • Cobalt HF Quad: DTPB2QQ, DTPB2Q1;
  • Crome VR: DVPC3D1, DVPC3D4;
  • Crome DR: DDPC3D1, DDPC3D4;
  • Crome HF: DTPC2D4, DTPC2D1;
  • Crome HF Quad: DTPC2QQ, DTPC2Q1

Recall Number: Z-0282-2022


The processing of collected episode data may fail due to a software error.


Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on 10/12/2021. Voluntary:  Firm Initiated recall is ongoing.


232 units


U.S. Nationwide

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:




Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now



Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.