The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2059-2020·Announced 2020-06-03

Heartware HVAD Pump Implant Accessories Recalled for Potential Component Failure

Heartware, Inc. is recalling HVAD Pump Implant accessories due to potential tears in the outflow graft and breakage of the strain relief screw during assembly.

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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump."

Plain-English summary

Heartware, Inc. is recalling Heartware HVAD Pump Implant accessories, Product (REF) Number 1153. The recall involves 560 units that were distributed worldwide.

The recall was issued because the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. The source text does not specify if any injuries or illnesses have been reported.

Healthcare providers and patients should contact Heartware, Inc. for further instructions regarding the recall. The source text does not provide specific consumer action steps beyond the recall notification.

The recalled product

Product
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
560

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 (2)

  • GTIN 00888707000147
  • All lot numbers in distribution

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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