Pain-Qualified Prospect Feed

Validated Workflow

The “Recall Aftershock”

Using the FDA Enforcement database to identify medical device companies that executed Class I or Class II recalls in the past 3–12 months — at the exact moment post-recall urgency unlocks budget for quality system modernization.

How It Works

Pull new Class I and Class II device recalls weekly from the FDA Enforcement database — structured data with company name, product, recall reason, classification, and distribution scope.
Filter for design, software, and manufacturing root causes (excluding labeling and packaging issues) to isolate recalls that signal systemic quality system gaps.
Enrich each recalling firm with company size, device portfolio breadth, and whether they’ve had prior recalls in the past 3 years.
Look up VP Quality, VP Regulatory Affairs, and Director of Quality Systems contacts with verified email and phone.
Build a lead card for each target: the specific product recalled, the root cause, the recall classification, and a personalized outreach angle referencing the exact quality failure.

Data Source

FDA Enforcement Database

Refresh Rate

Weekly

Monthly Volume

15–25 targets

Validation

24 / 25 — PASS

Sample Lead Cards

Real companies pulled from the FDA Enforcement database — each with a validated recall signal and a clear quality system pain point.

Highest Severity

Abiomed, Inc.

Danvers, Massachusetts

Class I Recall

Product Automated Impella Controller (AIC) — left heart support device

Root Cause Purge pressure issues due to purge retainer failures in the Automated Impella Controller — mechanical/design failure in a life-support system

Signal Class I = reasonable probability of serious health consequences or death. Worldwide distribution across 30+ countries.

Date October 29, 2025 — 3.5 months ago, in the active remediation window

Elekta, Inc.

Atlanta, Georgia

Class II Recall

Product MOSAIQ Oncology Information System with Particle Therapy

Root Cause Treatment unit doesn’t check meterset value — risk of overtreatment in radiation therapy

Signal Software-caused recall in oncology. Missing safety validation in particle therapy dosing scenario.

Date January 21, 2026 — 3 weeks ago

mo-Vis BVBA

Nevele, Belgium

Class I Recall

Product IDM-MICRO-R electrical wheelchair component

Root Cause Firmware timing variations between software tasks may skip necessary neutral check — wheelchair could move unexpectedly

Signal Class I recall for safety-critical firmware bug. Small European company with likely limited QMS infrastructure.

Date September 10, 2025 — 5 months ago

CareFusion 303, Inc. (BD)

San Diego, California

Class II Recall

Product BD Pyxis MedStation and Pro models — automated medication dispensing cabinets

Root Cause Firmware update caused duplicate address errors — inability or delay in accessing stored medications

Signal 53,669 units affected worldwide. Software change management failure — update deployed without adequate regression testing.

Date December 31, 2025 — 6 weeks ago

Backup Workflows (Passed Theoretical Evaluation)

The “Warning Letter Wake-Up Call” — Targets medical device companies that received an FDA warning letter citing Quality System Regulation deficiencies (CAPA, design controls, complaint handling). Warning letters carry 15-day response deadlines and near-certain budget unlock for QMS modernization. Approximately 3–4 targets per month.
The “510(k) Growth Crunch” — Identifies companies that received multiple FDA 510(k) clearances in the past 24 months and are now scaling faster than their quality system can support. Growth-positive framing with 5–8 new targets per month crossing the threshold.
The “MAUDE Adverse Event Spike” — Catches medical device companies showing a statistically significant increase in adverse event reports before the FDA acts on it. An early-warning signal that precedes formal enforcement by 6–18 months.
The “Post-Acquisition QMS Collision” — Targets recently acquired medical device companies facing the operational challenge of harmonizing two disparate quality management systems under one FDA registration. Sourced from industry M&A transaction data.
The “483 Repeat Offender” — Identifies companies that received FDA Form 483 observations in two or more consecutive inspection cycles for the same QSR subsections, signaling that prior corrective actions failed and escalation to a warning letter is likely.
The “EU MDR Certification Bottleneck” — Targets US-based device companies approaching the EU MDR transition deadline (EUDAMED mandatory May 2026) with unfinished certifications and a 12–18 month Notified Body backlog blocking their path.

What You’re Looking At

The lead cards in this report aren’t a one-time research project. They’re a sample of what a Pain-Qualified Prospect Feed looks like — monitoring the FDA Enforcement database continuously and surfacing medical device companies with recall-driven quality system failures the moment the signal fires.

What the Feed Looks Like

Every Week

25–50 prospects, each with the recall signal, why it creates urgency, a ready-to-use outreach angle, and verified VP Quality / VP Regulatory contacts.

Week 1 Onboarding

ICP & Pain Signal Map for your vertical, outreach templates for each signal type, and a competitive landscape snapshot — all ready before the first feed ships.

Monthly Refinement

You tell us which prospects turned into meetings. We adjust signal weighting so the feed gets sharper every month.

The Guarantee

50 pain-qualified prospects with verified contact info in your first 30 days — or you don’t pay for the first month.

Built for B2B sales teams who'd rather have 50 reasons to call than 5,000 names to guess from.

Want to see the full Recall Aftershock list?

We’ll pull 25–50 device companies with active recall pain in your target segments, walk you through the data live, and show you exactly what lands in your inbox each week.

Book 15 Minutes