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
- 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 HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603
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.