Agency classClass IOur severity:Severe FDA (Devices)·Z-1266-2022·Announced 2022-06-29

HeartWare HVAD Battery Model 1650DE May Malfunction Due to Weld Defect

Medtronic is recalling HeartWare HVAD batteries (Model 1650DE) due to an internal weld defect that can cause battery malfunction and prevent proper charging. Approximately 429 affected batteries were distributed worldwide.

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: This recall is classified as FDA Class I, which requires a minimum severity score of 4. A weld defect affecting a battery component in a ventricular assist device creates risk of malfunction that could disrupt continuous power delivery to a life-critical cardiac device.

Plain-English summary

Medtronic Inc. is recalling HeartWare HVAD batteries, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) system. A total of 429 batteries with specific serial numbers are affected, carrying GTIN 00888707008778 with an expiration date of April 30, 2022.

The recalled batteries contain a weld defect affecting internal components. This defect can cause the battery to malfunction, resulting in failure to provide power or inability to hold a complete charge or recharge properly. The HVAD is a ventricular assist device used to support heart function in patients with advanced heart disease.

The affected batteries were distributed worldwide, including throughout the United States and in Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.

Patients or healthcare providers with affected HVAD systems should verify their battery serial number against the recall list and contact Medtronic or their healthcare provider to determine appropriate next steps. Do not discontinue device use without consulting a physician.

The recalled product

Product: HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Manufacturer: Medtronic Inc
Category: Medical Device — Cardiac / Heart Support
Hazard: weld-defect
battery-malfunction
power-failure
charging-failure
Affected units: 429

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 00888707008778. Serial numbers BAT935012
BAT935059
BAT935008
BAT935009
BAT935018
BAT935020
BAT935022
BAT935023
BAT935047
BAT934999
BAT935003
BAT935010
BAT935329
BAT934928
BAT934934
BAT935160
BAT935078
BAT934997
BAT935027
BAT935048

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medtronic Inc

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