HeartWare HVAD Instructions for Use and Patient Manual Recall
Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update guidance on intermittent alarm issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation update to address potential intermittent device issues, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
Heartware, Inc. is recalling the Instructions for Use (IFU) and Patient Manual for the HeartWare HVAD System. The recall covers 23,123 units, including 11,292 in the United States, distributed worldwide to locations including the US, Italy, Great Britain, Germany, and Japan.
The documents are being updated to advise clinicians that alarms resolving after a very short period may indicate an intermittent problem that can be evaluated by analyzing controller log files. The Patient Manual is also updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared, as this may also indicate an intermittent problem.
This update is part of a broader effort to improve safety communication regarding the device's alarm system. The recall is associated with the February 2021 Urgent Medical Device Notice and is also covered in recalls 87456 and 87604.
The recalled product
- Product
- Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB
- Manufacturer
- Heartware, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- All serial numbers as of February 26
- 2021. Model
- GTIN: 1100
- No GTIN Available
- 1101
- 1102
- 1103
- 00888707000017
- 1104
- 1104JP
- 00888707000697
- 1205
- MCS1705PU
- 00888707005364
- 1403US
- 00888707000475
- 1407AU
- 00888707001663
- 1407CA
- 00888707002851
Distribution
Distributed nationwide across the United States.
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