HeartSine Samaritan Public Access Defibrillators (PAD) 350P, 360P, 500P
This statement has been updated to include new information about replacement devices, and Stryker has also identified 2 additional problems for this product. The customer recommendations remain the same.
If you have not done so already, check and register impacted devices via the website link and provide shipping details for replacement product: https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp
Once your response is received, Stryker will contact you to organise a replacement device.
Stryker has experienced delays in the availability of replacement devices. Replacement units are currently being allocated and shipped to customers. All replacement units will be supplied by 31 May 2027.
Stryker recommends keeping your HeartSine Samaritan PAD in service until a replacement device is available.
What is the problem?
Stryker is conducting an Urgent Recall of certain serial numbers of the HeartSine Defibrillators. A manufacturing problem related to a circuit board component may impair the device’s ability to function or cause failure. This failure could occur at any point when the device is holding a charge. This may be in preparation to deliver therapy, while delivering a shock, or after shock delivery.
The device becomes inoperable after the failure occurs.
The problem was observed during quality testing and not during patient use.
Additional problems identified:
- A problem with the membrane tail, an internal component, may result in an intermittent fault. This failure could occur at any point when the device is holding a charge in preparation to deliver therapy, while delivering a shock, or after shock delivery. If this failure occurs, the device becomes inoperable.
- A limited number of HeartSine Samaritan PAD devices were distributed without the required maintenance supplement. This supplement contains periodic maintenance instructions implemented as an additional risk control measure.
| ARTG number | Catalogue number | Product model | Affected serial numbers |
|---|---|---|---|
| 156690, 228210 | 350BASUK10 | HeartSine SAM 350P | A subset of serial numbers have been affected by this notice. Please check if your AED serial number is affected by visiting the HeartSine PFA Global Landing Page below: |
360BASUK10 360BASUKGW | HeartSine SAM 360P | ||
| 500BASUK10 | HeartSine SAM 500P |
What are the risks?
The problem could lead to:
- No shock delivery
- Delay in treatment
What should I do?
- Contact Styker via email on heartsine.recall@stryker.com or call on 02 9170 9131. You can also notify Stryker via https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp.
- Once your response is received, Stryker will contact you to organise a replacement device.
- In the meantime, Stryker recommends keeping your HeartSine Samaritan PAD in service until a replacement device is available.
- Download a copy of the missing maintenance supplement vis the link above and store with your device’s user manual until a replacement is received. It is recommended that the supplement is stored with your user manual/user handbook and AED and follow the additional check once every 3 months.
Further information
Please contact Stryker on 02 9170 9131 or email heartsine.recall@stryker.com for further information.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.