Recall record at a glance
| Official record | Z-1512-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Heartware, Inc. |
| Report date | Aug 24, 2022 |
| Recall initiation date | Jun 28, 2022 |
| Quantity | 19616 batteries |
| Location | Miami Lakes, FL, United States |
Official product description
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Why the product was recalled
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Distribution information
Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.