Recall MonitorHealth Products
HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P - Membrane Tail
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P - Membrane Tail
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| HeartSine samaritan PAD 500P | More than 10 numbers, contact manufacturer. | 500-STR-CN-10 |
| HeartSine samaritan PAD 500P | More than 10 numbers, contact manufacturer. | 500-BAS-CN-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-BAS-CN-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-BAS-CF-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-STR-CN-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-TSO-CN-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-TSO-CN-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-BAS-CN-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-BAS-CF-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-STR-CN-10 |
Issue
Stryker has recently identified an issue with the membrane tail, an internal component, which could cause 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. The device becomes inoperable after the failure occurs.