Quick answer
The 350P is the best compact AED for homes and small facilities: 2.4 lbs, the best water and dust rating in its class (IP56), one combined pads-plus-battery cartridge to maintain, an 8-year warranty, and it is the only compact AED approved for over-the-counter sale. It costs $1,411 new ($1,261.50 with the current in-cart discount, AED Leader, 17 Aug 2026) or $875 recertified. Buy it with open eyes: the current HeartSine family has three open FDA Class 2 recalls, covered in full below with the serial check that settles whether any unit is affected.
Verified pricing, August 2026
Quick answer
$1,411 new, $1,261.50 with the in-cart discount, $1,461.50 for the accessory package, $875 recertified with a 3-year warranty. The fully-automatic 360P and the CPR-advisor 450P ($1,761) cost more.
| Configuration | Price | Source, date |
|---|---|---|
| 350P new (SKU 350-STR-US-10), pads + battery pre-installed, carry case | $1,411 ($1,261.50 in cart) | AED Leader, 17 Aug 2026 |
| 350P value package (adds accessories) | $1,461.50 | AED Leader, 17 Aug 2026 |
| Recertified HeartSine samaritan, 3-yr warranty | $875 | AED Leader, Aug 2026 |
| HeartSine 450P new (CPR Rate Advisor) | $1,761 | AED Leader, Aug 2026 |
| Adult Pad-Pak (pads + battery, one cartridge) | $236 | AED Leader, Aug 2026 |
| Pediatric Pad-Pak | $279 | Network seller, Aug 2026 |
Stock note: the 350P showed “in stock (can be backordered)” at the check date. The recertified HeartSine breakdown covers what recertification includes and who should take the $875 route.
The over-the-counter status nobody cites
Quick answer
The 350P is approved for over-the-counter use under FDA PMA P160008, supplement S017, decided June 23, 2022. Its siblings, the 360P and 450P, remain prescription devices. That makes the 350P the only sub-3-lb AED a household can buy with zero paperwork.
Every AED sold in the US is FDA-approved via Premarket Approval. Almost all of them carry prescription labeling, which dealers handle for you. Only two device families are approved for true over-the-counter sale, and the 350P is one of them (the other is the Philips OnSite/Home adult configuration). If OTC status matters to your purchase, the model matters: the S017 supplement names the 350P alone, so a 360P or 450P is still a prescription sale. Our best AED for home guide puts this in context against every rival.
One-SKU Economics: the Pad-Pak advantage
Quick answer
Every other AED makes you track two expiry dates: pads (2 to 5 years) and battery (4 to 5 years). HeartSine puts both in one $236 cartridge with one date. In September 2025 the FDA approved extending Pad-Pak shelf life to 5.25 years from date of manufacture. Ten years of consumables costs about $472, or roughly $47 a year.
This is the feature that makes the 350P the lowest-friction AED to own. One cartridge, one calendar entry, one $236 purchase per cycle. The FDA approval of the shelf-life extension (P160008 supplement S030, September 2025) supersedes the 4-year figure still printed on older HeartSine data sheets; real in-service life depends on the manufacture date stamped on your specific Pad-Pak, so check the date when it arrives. FDA failure data explains why this design matters: batteries plus pads and connectors account for about 46.9% of the 40,787 AED failures reported to the FDA in a landmark review (DeLuca et al., Annals of Emergency Medicine, 2012). Fewer things to track means fewer ways to be dead on the shelf.
| Model | Consumables, 10 years (our calculation) | Expiry dates to track |
|---|---|---|
| ZOLL AED Plus | $330 | 2 |
| ZOLL AED 3 | $435 | 2 |
| HeartSine 350P | $472 | 1 |
| Philips FRx | $854 | 2 |
| Philips OnSite | $894 | 2 |
| Powerheart G5 | $1,342 | 2 |
Full part numbers and prices live in our pads and batteries guide. The ZOLL AED Plus beats the 350P on raw decade cost; the 350P beats everything on simplicity, weight, and OTC status. Pick your priority.
Specs, and what it is like to use
Quick answer
2.4 lbs, IP56, semi-automatic two-button operation, SCOPE escalating biphasic waveform, visual and voice CPR prompts, 8-year warranty. It is the AED you forget is in the bag until you need it.
| Spec | HeartSine 350P | Why it matters at home |
|---|---|---|
| Weight | 2.4 lbs, lightest US AED | Lives in a kitchen drawer or travel bag, not a wall case |
| Ingress rating | IP56 | Best dust and water protection of any mainstream AED; also why it shows up in our gym guide |
| Operation | Semi-automatic, 2 buttons | On button, shock button, nothing else to misuse |
| Waveform | SCOPE escalating biphasic | Adjusts energy to the patient across shocks |
| CPR guidance | Voice + flashing icon prompts | Coaches rhythm; it does not measure compression depth, the ZOLL models do |
| Warranty | 8 years | Longest in the compact class |
In use, the 350P’s coaching is clear but leaner than the Philips OnSite’s step-by-step narration, and it lacks the compression-depth feedback of a ZOLL AED Plus. Untrained buyers who want maximum hand-holding should read the OnSite review before deciding. Confident buyers who want the smallest, toughest, simplest-to-maintain device are already in the right place.
The recall record, printed in full
Quick answer
The current 350P/360P/450P family has three open FDA Class 2 recalls initiated between April 2023 and June 2025, one of which concerns shock delivery. None is the Class 1 from 2012, which belongs to the discontinued Samaritan 300/300P. Anyone owning or buying a HeartSine should check the serial number against the FDA listing. A recertified purchase from a reconditioner that documents serial history does this for you.
We could not find this table on any other page ranking for this search, including the current #1. Here it is, from the FDA recall databases (pulled 30 Jul 2026):
| FDA recall | Initiated | What FDA says | Class | Status |
|---|---|---|---|---|
| Z-2174-2025 (event 96890) | Jun 30, 2025 | "Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)". 190,516 devices, US + 23 countries | 2 | Ongoing |
| Z-1820-2024 (event 94076) | Apr 8, 2024 | Could fail to deliver instructional voice prompts. 183,248 devices | 2 | Open |
| Z-2143-2023 (event 92346) | Apr 26, 2023 | Pad-Pak depleted battery cells could prevent analysis or therapy. 30,022 units | 2 | Open |
Reading this honestly in both directions: reported quantities across the three records sum to 403,786, though the affected populations may overlap, so that is a records sum, not a count of unique devices. Class 2 means the defect can cause temporary or reversible harm or that serious harm is improbable, and HeartSine (a Stryker company) issued correction instructions rather than a stop-use order. The 2012 Class 1, which HeartSine critics sometimes wave around, applies to the discontinued 300/300P and not to any current model. The action item is the same either way: check your serial number against the FDA recall listing for Z-2174-2025 or run the check through Stryker’s recall portal, five minutes that settles the question for your specific unit. Our refurbished buying guide explains why serial-documented reconditioners are the safest source for exactly this reason.
350P vs 360P vs 450P: which samaritan
Quick answer
350P: semi-automatic, over the counter, cheapest. 360P: fully automatic (shocks without a button press), prescription. 450P: adds a real-time CPR Rate Advisor, prescription, $1,761. Same body, same Pad-Pak, same warranty on all three.
| 350P | 360P | 450P | |
|---|---|---|---|
| Shock delivery | Semi-auto (press button) | Fully automatic | Semi-auto |
| CPR rate feedback | Prompts only | Prompts only | Rate Advisor (measures pace) |
| Consumer sale | Over the counter (S017) | Prescription | Prescription |
| Price (Aug 2026) | $1,411 | ask seller | $1,761 |
| Best for | Homes, travel, small offices | Buyers who fear hesitation | Workplaces wanting CPR quality data |
The honest tiebreaker: hesitation is real in a crisis, and a fully automatic 360P removes the one decision left. But it is a prescription device and usually costs more, and the AHA has not shown a survival difference between semi and fully automatic public AEDs. Most homes should keep the $350-plus difference and take the OTC 350P.
How it stacks against the field
Against the Philips OnSite: the Philips coaches better, the HeartSine is half the weight, tougher (IP56 vs IP21), and about $470 less in decade consumables. Against the ZOLL AED Plus: the ZOLL measures compression depth and owns the cheapest decade ($330), the HeartSine is 3 lbs lighter and OTC (full math in the refurbished vs new guide). Against its own recertified self: $875 recertified is the value pick if the 3-year warranty is enough for you, $536 less than new at the current cart price. Families choosing around children should also read the ZOLL AED 3 review, whose Uni-padz make pediatric coverage free (see also the AED 3 vs AED Plus comparison), and our schools guide for the institutional version of that math. The broader rankings live in best AEDs of 2026 and the HeartSine brand hub.
The one-line decision
Buy the 350P if you want the lightest, toughest, simplest-to-maintain AED and OTC purchase: $1,411 new, $1,261.50 at the current cart discount, or $875 recertified with a 3-year warranty. Buy a ZOLL instead if compression-depth coaching or lowest decade cost is your deciding factor.
FAQ
Is the HeartSine 350P good for home use?
Yes, it is our best-compact pick for homes: 2.4 lbs, one cartridge to maintain, an 8-year warranty, and it is the only compact AED approved for over-the-counter sale. See the best AED for home rankings for how it compares.
What does the 350P cost?
$1,411 new with pads and battery included, $1,261.50 with the seller’s current in-cart discount, $1,461.50 as a package (AED Leader, 17 Aug 2026), or $875 recertified with a 3-year warranty.
How long does the Pad-Pak last?
The FDA approved extending Pad-Pak shelf life to 5.25 years from the date of manufacture (P160008 supplement S030, September 2025), superseding the 4-year figure on older data sheets. Check the manufacture date on your specific cartridge; in-service life depends on it. Replacement cost is $236.
Do I need a prescription to buy one?
Not for the 350P: it is approved for over-the-counter use under FDA PMA P160008, supplement S017 (June 2022). The 360P and 450P are prescription devices, which dealers handle as part of the sale.
Is the HeartSine 350P recalled?
The 350P/360P/450P family has three open FDA Class 2 recalls (2023, 2024, 2025), including one for shock delivery. Whether your unit is affected depends on its serial number: check it against the FDA listing for recall Z-2174-2025 or through Stryker. The 2012 Class 1 recall applies to the discontinued 300/300P, not current models. Status as of the FDA record pull of 30 Jul 2026.
What is the difference between the 350P and 360P?
The 360P is fully automatic: it delivers the shock without a button press. The 350P is semi-automatic and sold over the counter. Size, Pad-Pak, warranty, and waveform are identical.
References
- FDA Premarket Approval database, P160008 (HeartSine samaritan PAD 350P/360P/450P), including supplement S017 (prescription to OTC, 23 Jun 2022) and S030 (Pad-Pak shelf-life extension to 5.25 years, Sep 2025).
- FDA recall records: Z-2174-2025 (event 96890, enforcement database: component manufacturing issue, may not deliver shocks, 190,516 devices, ongoing), Z-1820-2024 (event 94076, voice prompts, 183,248 devices), Z-2143-2023 (event 92346, Pad-Pak battery cells, 30,022 units), and the 2012 Class 1 on the discontinued Samaritan 300/300P (event 63139). Status as pulled 30 Jul 2026.
- DeLuca LA et al. Analysis of automated external defibrillator device failures reported to the Food and Drug Administration. Ann Emerg Med. 2012 (PMID 21872969).
- American Heart Association: out-of-hospital cardiac arrest statistics and defibrillation survival decline per minute.
- Seller prices: AED Leader 350P product page (SKU 350-STR-US-10) checked 17 Aug 2026; recertified and 450P pricing checked Aug 2026.
Updated August 2026. Recall status and prices re-verified on the dates shown; tell us if either has moved since.
