By Duane Tinker, The Toothcop
Every dental practice that provides sedation—or simply wants to be prepared for medical emergencies—should have an Automated External Defibrillator (AED) readily available.
When those life-saving devices are subject to a recall, it’s not just a manufacturer issue.
It becomes a risk management and patient safety issue for the practice.
Recently, a recall involving HeartSine samaritan PAD Automated External Defibrillators (AEDs) and certain Pad-Pak battery/electrode cartridges has raised questions for healthcare offices, including dental practices.
Let’s break down what’s happening, what the actual risk is, and what responsible practices should do next.
First, Why AEDs Matter in Dentistry
Sudden cardiac arrest can occur anywhere—including dental offices.
AEDs are designed to quickly analyze heart rhythm and deliver a shock if needed to restore a normal rhythm. Early defibrillation significantly improves survival rates in cardiac arrest emergencies. (American Heart Association guidance consistently emphasizes early defibrillation as a key link in the “chain of survival.”)
That’s why many sedation guidelines and emergency preparedness protocols strongly encourage or require an AED in the office.
Which is exactly why equipment reliability matters.
What the HeartSine Recall Is About
In June 2025, Stryker issued a voluntary recall involving certain HeartSine samaritan PAD AED models, including:
· SAM 350P
· SAM 360P
· SAM 450P
· SAM 500P
The recall affects a subset of devices with serial numbers beginning with 21, 22, 23, or 24 followed by the letters B, D, E, G, or H.
The issue involves a manufacturing defect in a circuit board component that could impair the device’s ability to function properly.
If the defect occurs, the AED may:
· Fail to deliver the intended therapy
· Delay treatment during a cardiac arrest
· Become inoperable during or after shock delivery
The problem was discovered during internal quality testing, not during real-world patient use. No adverse patient events have been reported related to this specific defect.
However, because AEDs are used in high-stakes emergencies, even a small risk requires action.
A Separate Recall: HeartSine Pad-Pak Cartridges
In addition to the AED device recall, the FDA has documented a recall involving certain HeartSine Pad-Pak cartridges, the combined battery and electrode system used with these AEDs.
The issue involves potential damage to locator pins, which could disrupt electrical contact when inserted into the device.
If the cartridge does not seat correctly, it could affect the AED’s ability to function during an emergency.
The FDA classified this as a Class II medical device recall, meaning the issue may cause temporary or medically reversible adverse health consequences.
The Real Risk (and Why Context Matters)
It’s important not to overreact—and also not to ignore the issue.
According to the manufacturer:
· The probability of device failure is considered low.
· The defect was discovered during testing rather than patient use.
· No injuries or deaths have been reported from the issue.
Because of this, Stryker advises that if no alternative AED is available, organizations should continue using the device until a replacement is provided.
In other words:
A functioning AED—even one subject to recall—is still better than having no AED available at all during a cardiac emergency.
What Dental Practices Should Do Right Now
If your office has a HeartSine AED, here are the responsible steps to take.
1. Check Your AED Model and Serial Number
Locate the serial number on the back of the device and determine whether it falls within the affected range.
Stryker provides an online lookup tool to verify affected devices.
2. Inventory Your Emergency Equipment
This is a good reminder to verify:
· AED model and serial number
· Pad-Pak expiration date
· Spare cartridges
· Emergency drug kit inventory
Equipment failures rarely occur at convenient times.
3. Follow Manufacturer Instructions
If your AED is affected:
· Document the serial number
· Respond to the recall notification
· Arrange for replacement or corrective action
Manufacturers typically provide replacement devices or components as part of recall remediation.
4. Maintain Emergency Preparedness
The most important thing is not the recall itself.
It’s ensuring your team still knows how to respond to a medical emergency.
That means:
· Regular emergency drills
· Staff training in CPR and AED use
· Verifying equipment readiness
Because when an emergency happens, preparation—not paperwork—is what saves lives.
A Compliance Lesson Hidden in This Recall
Equipment recalls are not uncommon in healthcare.
What matters is how organizations respond.
Strong compliance and risk management systems ensure that practices:
· Monitor safety alerts
· Track equipment serial numbers
· Respond to manufacturer notices
· Document corrective actions
That’s not bureaucracy.
That’s how responsible healthcare organizations protect patients—and themselves.
Final Takeaway
If your practice owns a HeartSine AED, this recall is simply a reminder to:
1. Verify your device
2. Follow the manufacturer’s instructions
3. Maintain emergency readiness
Recalls happen.
Prepared practices respond quickly, document appropriately, and keep moving forward.
Because in a real emergency, the goal is simple:
Have the right equipment ready—and know how to use it.
Call to Action
Medical emergencies in dental offices are rare—but when they happen, preparation is everything.
References
Stryker Recall Notice: https://www.stryker.com/ca/en/emergency-care/product-notices/heartsine/fa111-t0.html
· FDA Recall Notice: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=213872
· TSBDE Notice: https://tsbde.texas.gov/78i8ljhbj/HeartSine-Notice.pdf