Documentation errors recalled in HeartWare HVAD instructions and manuals
Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.
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: FDA Class II recall of instructional materials for a life-sustaining medical device. Errors and inconsistencies in instructions could affect proper device use.
Plain-English summary
Medtronic is recalling instruction and guidance documents for the HeartWare Ventricular Assist Device (HVAD) System due to errors and inconsistencies identified in the materials. The recalled items include Instructions for Use (IFU), Patient Manuals (PM), and Emergency Responder Guides (ERG).
The recall affects 21,118 pieces of product literature distributed worldwide, including throughout the United States and to 20 international countries. The affected documentation was distributed as part of pump implant kits (models 1103, 1104, 1104JP, and MCS1705PU) and as standalone documents with various catalog numbers.
Patients who have received the HVAD system should contact their healthcare provider or Medtronic directly to obtain corrected documentation.
The recalled product
- Product
- Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
- Manufacturer
- Medtronic Inc
- Affected units
- 21,118
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)
- Device Model numbers affected: 1104: GTIN 00888707002028
- Serial Numbers: HW28848
- HW29011
- HW29154
- HW29199
- HW29211
- HW29212
- HW29219
- HW29229
- HW29246
- HW29248
- HW29249
- HW29252
- HW29265
- HW29266
- HW29268
- HW29271
- HW29273
- HW29274
- HW29276
Distribution
Distributed nationwide across the United States.
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