The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2055-2020·Announced 2020-06-03

Heartware Recalls HVAD Pump Implant Kits Due to Graft Tears and Screw Breakage

Heartware, Inc. is recalling 2,614 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant 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 2,614 units of the Heartware HVAD Pump Implant Kit, Product (REF) Number 1103. The recall covers kits distributed worldwide.

The recall is being 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. These defects could compromise the integrity of the device before it is implanted in a patient.

Healthcare providers and patients should contact Heartware, Inc. for instructions on how to proceed with the recall. The source text does not specify a particular action for consumers beyond the recall notice itself.

The recalled product

Product
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Manufacturer
Heartware, Inc.
Category
Medical Device — Implantable Pump
Hazard
Affected units
2,614

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)

  • GTIN 00888707000017
  • Serial Numbers: HW26899
  • HW27283
  • HW27893
  • HW28873
  • HW28999
  • HW29422
  • HW29488
  • HW29722
  • HW30166
  • HW30170 GTIN 00888707002639
  • Serial Numbers: HW29525
  • HW30015
  • HW30297
  • HW30477
  • HW31174
  • HW31179
  • HW31181
  • HW31246
  • HW31247

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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