The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2056-2020·Announced 2020-06-03

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

Heartware, Inc. is recalling 2,225 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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric, despite the lack of reported injuries in the source text.

Plain-English summary

Heartware, Inc. is recalling 2,225 units of the Heartware HVAD Pump Implant Kit, Product (REF) Number 1104. The recall covers units distributed worldwide. The specific hazard identified is that 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.

This recall is classified as Class I by the U.S. Food and Drug Administration. The defect is identified during the pre-implant assembly process, which is a critical step before the device is placed in a patient. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare providers and facilities should check their inventory for the affected serial numbers listed in the official recall notice. Consumers with implanted devices should contact their healthcare provider for guidance on whether their specific device is affected and what steps to take.

The recalled product

Product
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
2,225

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 00888707002028
  • Serial Numbers: HW28848
  • hw29011
  • HW29154
  • HW29211
  • HW29248
  • HW29249
  • HW29273
  • HW29329
  • HW29426
  • HW29465
  • HW29472
  • HW29522
  • HW29534
  • HW29548
  • HW29549
  • HW29567
  • HW29588
  • HW29593
  • HW29602

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 →

Related recalls

Same manufacturer · Heartware, Inc.

See all →

Same hazard · structural failure

See all →

Similar recalls