When experience matters...

With the advent of software-driven devices, mobile applications and AI, recall and field action management has never been more complex. AlphaPath Recall and Transformation Management consultants have the experience necessary to support you from start to closure.

+20

+100

Recalls executed

Years of experience

Matt Wolf | Founder | AlphaPath

Project Management and Communications Certified Professionals

Our work

A summary of select recalls planned, developed and executed by AlphaPath's consultants

An incorrect algorithm was triggering premature “end‑of‑life” alerts in implantable cardiac monitors distributed globally by a major medical device manufacturer. The issue affected a large installed base and blocked the planned launch of the company’s second‑generation monitors, demanding a rapid, highly coordinated response.

A targeted communication strategy informed physicians and impacted patients while a software correction was developed and submitted for regulatory approval. Following approval, an innovative second phase of the recall used patients’ home companion monitors to remotely deploy the software update and confirm successful installation on affected devices, restoring performance, rebuilding stakeholder confidence, and enabling the second‑generation launch to proceed with minimal disruption.

Algorithm-driven recall unblocks next‑generation launch

Results at a glance

Restored performance of affected implanted cardiac monitors
Removed a critical barrier to second‑generation product launch
Minimized disruption for physicians and patients through remote updates

Manufacturing defect recall mitigates life-critical ICD/CRT-D risk

A manufacturing process defect created an elevated risk that select ICD and CRT-D devices could fail to deliver pacing therapy or revive patients during cardiac arrest. Given the heightened potential for patient injury or death, rapid identification of affected populations and coordinated stakeholder communications were essential.

The recall team worked swiftly with an independent physician quality panel, patient services organizations, and warranty services to execute deployment. As a Class I recall, AlphaPath consultants provided critical support during FDA investigations, preparing staff to address regulator and patient concerns effectively.

AlphaPath consultants orchestrated the high-stakes recall strategy, bridging clinical, regulatory, and patient support teams to protect lives while maintaining compliance under intense FDA examination.

Results at a glance

Swiftly identified and notified all affected patients and physicians
Coordinated multi-stakeholder recall execution with zero delays
Strengthened regulatory preparedness for Class I FDA scrutiny

Aging External Pacemaker Recall Ensures Global Field Recovery

Select external temporary pacemakers were found to have risks of failing to power up or unexpectedly powering down during use, potentially interrupting critical pacing therapy for patients. The challenge was compounded by the devices’ age (some over 20 years old) and global distribution, requiring extensive research to locate impacted units.

The recall strategy coordinated repair services to service affected devices while deploying loaner units to maintain patient care continuity, carefully balancing repair capacity. Ultimately, the initiative successfully located and reconciled the vast majority of devices, returning them for service.

AlphaPath's consultants managed the complex global logistics, from inventory tracing and stakeholder coordination to repair planning and loaner deployment, ensuring patient safety while overcoming significant field action obstacles.

Results at a glance

Located 20+ year-old devices dispersed globally via targeted research
Coordinated repairs and loaners without exceeding service capacity
Achieved high recovery rate, restoring field safety