HeartWare® Battery Charger 1600USRecalls & reported problems
Heartware Inc. · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This HeartWare battery charger charges batteries for a heart-assist pump system. The 23 reports mostly describe chargers put together with the wrong internal part during manufacturing, plus a loose power connection that led to intermittent charging. There are 23 adverse event reports that name its identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888707000130), received between Aug 14, 2018 and Aug 16, 2021 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (18 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping18
- Component Misassembled4
- Electrical Power Problem1
- Failure to Charge1
Patient problems
- No Known Impact Or Consequence To Patient21
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2021Failure to Charge; Electrical Power Problem; Failure to Charge; Electrical Power Problem
IT WAS REPORTED THAT THE BATTERY CHARGER WAS INTERMITTENTLY CHARGING BATTERIES. IT WAS NOTED THAT THE POWER CABLE DID NOT STAY PLUGGED INTO THE BASE OF THE CHARGER, IT WAS VERY LOOSE. THE BATTERY CHARGER HAS BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12324822 ↗MalfunctionOct 30, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8020527 ↗MalfunctionOct 30, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8020295 ↗MalfunctionOct 26, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8010032 ↗MalfunctionOct 24, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS, THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8001721 ↗MalfunctionOct 23, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7997309 ↗MalfunctionOct 23, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7997110 ↗MalfunctionOct 23, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7996527 ↗MalfunctionOct 23, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7995468 ↗MalfunctionOct 22, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7992947 ↗MalfunctionOct 10, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7952338 ↗MalfunctionOct 5, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7939192 ↗MalfunctionOct 3, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7931628 ↗MalfunctionSep 24, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS,THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7903602 ↗MalfunctionSep 24, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED, BY PRODUCT ANALYSIS, THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7903104 ↗MalfunctionSep 18, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE BATTERY CHARGER WAS NOT CHARGING ON A SINGLE PORT. THE BATTERY CHARGER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7887148 ↗MalfunctionSep 18, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WILL BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7887047 ↗MalfunctionSep 18, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7886983 ↗MalfunctionSep 12, 2018Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT PRODUCT ANALYSIS INDICATED THAT THE INCORRECT INDUCTOR WAS USED DURING THE ASSEMBLY PROCESS. THE BATTERY CHARGER WILL BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7869038 ↗MalfunctionAug 31, 2018Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE BATTERY CHARGER WAS NOT CHARGING BATTERIES ON MULTIPLE PORTS AND ONE OF THE LIGHT EMITTING DIODES (LEDS) DID NOT ILLUMINATE. PRODUCT ANALYSIS INDICATED THAT AN INCORRECT INDUCTOR WAS USED IN THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7837817 ↗MalfunctionAug 20, 2018Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE BATTERY CHARGER WAS NOT CHARGING ON A SINGLE PORT. PRODUCT ANALYSIS INDICATED THAT AN INCORRECT INDUCTOR WAS USED IN THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7798324 ↗MalfunctionAug 20, 2018Component Misassembled; Component Misassembled
IT WAS REPORTED THAT WHILE A BATTERY WAS SUCCESSFULLY CHARGING ON A SINGLE PORT OF THE BATTERY CHARGER THE STATUS AND READY LIGHTS WOULD NOT LIGHT UP. PRODUCT ANALYSIS INDICATED THAT AN INCORRECT INDUCTOR WAS USED IN THE ASSEMBLY PROCESS. THE BATTERY CHARGER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7798075 ↗MalfunctionAug 14, 2018Component Misassembled; Component Misassembled
IT WAS REPORTED THAT ONE OF THE PORTS OF THE BATTERY CHARGER WAS NOT CHARGING THE BATTERIES. THE BATTERY CHARGER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7781653 ↗
Other Ventricular (Assisst) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
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- Thoratec® HeartMate 3™ 106531USThoratec Corporation · Ventricular (Assisst) Bypass1 recall11 deaths4,646 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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