HeartWare HVAD Pump Driveline Splice Kit Recalled for Failure Risk
HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
HeartWare Inc is recalling 35 units of the HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit. The recall is due to a risk that the splice repair kit may fail if exposed to excessive force. The product is intended to repair the driveline cable once an electrical break has been identified, specifically for the portion of the driveline outside the patient boundary.
The affected products include Catalog # ASY00116 (Lot #s 532770, 567949, 480786, 483769, 490692, 539664, and 598189) and Catalog # ASY00281 (Lot #s 654090, 672401, 678800, 690423, 833963, 873159, and 880816). These units were distributed nationwide in the United States (specifically in FL, KY, MO, NY, TN, and TX) and internationally in Canada, Germany, Italy, the Netherlands, Turkey, and the United Kingdom.
Healthcare providers and patients should contact HeartWare Inc for instructions on how to proceed with the recall. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit…
- Manufacturer
- HeartWare Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 35
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 (14)
- Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770
- 567949
- 480786
- 483769
- 490692
- 539664
- and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit
- Large OD Sheath Lot #'s 654090
- 672401
- 678800
- 690423
- 833963
- 873159
- and 880816
Distribution
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