HeartWare HVAD Instructions for Use and Patient Manual Labeling Correction
Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HVAD System to correct inaccurate descriptions of controller connection verification.
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 labeling error regarding device operation. As no injuries or illnesses are reported and the hazard is theoretical, it aligns with the Moderate severity criteria for minor labeling errors.
Plain-English summary
Heartware, Inc. is recalling the Instructions for Use and Patient Manual for the HeartWare HVAD System. The recall affects 23,123 units, including 11,292 in the United States, which were distributed nationwide and in Italy, Great Britain, Germany, and Japan.
The labeling is being corrected to accurately describe the behavior of a successful connection to the HVAD controller. The manual previously stated that a successful connection produces an "audible click," but the actual verified behavior is a "beep." The update clarifies the alarm conditions under which a beep will not be heard and identifies a visual indicator as an alternate method to confirm a successful connection.
This labeling update is also included in the February 2021 Urgent Medical Device Notice, which is covered in recalls 87456 and 87603. The recall is classified as Class II by the FDA.
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, 14
- Manufacturer
- Heartware, Inc.
- Hazard
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)
- Model
- GTIN: 1100
- No GTIN Available
- 1101
- 1102
- 1103
- 00888707000017
- 1104
- 1104JP
- 00888707000697
- 1205
- MCS1705PU
- 00888707005364
- 1403US
- 00888707000475
- 1407AU
- 00888707001663
- 1407CA
- 00888707002851
- 1407CH
Distribution
Distributed nationwide across the United States.
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