Reported Apr 28, 2021 · Ongoing
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices
3 of 3 products
| Model / number | Product as published |
|---|---|
1440. | Heartware HVAD data cable - monitor |
1575. | Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack |
1475. | Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US. |
- Lot codes and dates
All serial numbers as of February 262021. Model
- GTIN
88 of 88 codes
1100No GTIN Available1101No GTIN Available1102No GTIN Available1103008887070000171104No GTIN Available1104JP008887070006971205No GTIN AvailableMCS1705PU008887070053641403US008887070004751407AU008887070016631407CA008887070028511407CH008887070016941407DE008887070017001407GB008887070017171407IL008887070017241407IN008887070017311407IT008887070017481407JP008887070017551407KR008887070017621420008887070004201420JP008887070004371430AR008887070008261430AU008887070008331430CA008887070008571430CH008887070008711430DE008887070008641430GB008887070008881430IL008887070009011430IN008887070005051430IT00888707000895
- Amount recalled
- 23123 (11292 US)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new infant & baby recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.