Patient Pack 1475 (UDI 00888707000178)Recalls & reported problems
Heartware Inc. · Class 3
All models of Patient Pack (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This HeartWare patient pack for a ventricular assist (heart pump) system has 207 malfunction reports, with no deaths and no injuries. Most reports describe parts breaking, splitting or tearing, such as a broken clip, and several mention that the pack was replaced. Reports mention no patient complications. 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
- 206
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 00888707000178), received between Sep 5, 2017 and Dec 4, 2024 — classified as 206 malfunctions.
The most frequently reported specific device problem is “Break” (179 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break179
- Material Split, Cut or Torn17
- Material Integrity Problem6
- Adverse Event Without Identified Device or Use Problem2
- Component Missing2
- Device Fell2
- Material Frayed2
- Crack1
Patient problems
- No Known Impact Or Consequence To Patient132
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient30
- No Patient Involvement13
- Bruise/Contusion1
- Erythema1
Recent adverse event reports
The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CONTROLLER DISPLAY PART OF THE PIONEER CONVERTIBLE PATIENT PACK WAS TORN. THE PATIENT PACK WAS REPLACED BY A MEDTRONIC PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20843695 ↗MalfunctionNov 15, 2023Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED, THE CLIP WAS BROKEN. THE PATIENT'S PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18139537 ↗MalfunctionMar 24, 2023Break; Break
IT WAS REPORTED THAT CLIP ON THE PATIENT PACK BROKE. THE PATIENT PACK WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16610874 ↗MalfunctionSep 20, 2022Break; Break
IT WAS REPORTED THAT THE PATIENT PACK HAD A BROKEN CLIP. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15455780 ↗MalfunctionSep 20, 2022Break; Break
IT WAS REPORTED THAT THE PATIENT PACK CLIP WAS BROKEN. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15455719 ↗MalfunctionMar 18, 2022Break; Break
IT WAS REPORTED THAT THE PATIENT PACK HAD A BROKEN CLIP. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13805657 ↗MalfunctionMar 14, 2022Break; Break
IT WAS REPORTED THAT THE WAIST PACK WAS RIPPING WHERE THE CONTROLLER WAS HELD TO THE BELT. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13758345 ↗MalfunctionNov 29, 2021Break; Break
IT WAS REPORTED THAT THE VELCRO ON THE PATIENT PACK WAS NO LONGER STICKING AND ALSO PEELING OFF. THE PATIENT PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12887523 ↗MalfunctionNov 29, 2021Break; Break
IT WAS REPORTED THAT UPON OPENING THE BOX TO REPLACE AN OLDER DAMAGED PATIENT PACK, THE CLIP OF THE NEW PATIENT PACK WAS UNATTACHED AND BROKEN. THE PATIENT PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12884633 ↗MalfunctionOct 26, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED, IT HAD A TORN BACK AND BROKEN BUCKLE. THE PATIENT PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12698068 ↗MalfunctionOct 22, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS RIPPED AND WOULD NOT SECURELY HOLD THE BATTERIES OR CONTROLLER. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12682473 ↗MalfunctionAug 25, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS FALLING APART ON ONE SIDE. THE PATIENT PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12364992 ↗MalfunctionAug 6, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK HAD TORN STRAPS AND BROKEN CLIPS. THE PATIENT PACK WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12287929 ↗MalfunctionJul 23, 2021Component Missing; Component Missing
IT WAS REPORTED THAT THE PATIENT PACK HAD A MISSING CLIP. THE PATIENT PACK WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12217451 ↗MalfunctionJul 19, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED DUE TO A BROKEN CLASP. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12189439 ↗MalfunctionJun 15, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED, THE CLIP WAS BROKEN IN THE MIDDLE OF THE BUCKLE. THE PATIENT PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12000312 ↗MalfunctionJun 9, 2021Break; Break
IT WAS REPORTED THAT BUCKLE ON THE PATIENT PACK BROKE WHILE HELPING TO PREPARE FOR AN IMPLANT PROCEDURE. THE WAIST PACK WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11966954 ↗MalfunctionJun 9, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS DAMAGED WITH BROKEN CLIPS. THE PATIENT PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11966318 ↗MalfunctionMay 12, 2021Break; Break
IT WAS REPORTED THAT UPON TAKING THE PATIENT PACK OUT OF THE BOX, ONE OF THE CLIPS WERE NOTED TO BE BROKEN. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11813559 ↗MalfunctionApr 19, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK WAS BREAKING AT THE SEAMS. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11684840 ↗MalfunctionApr 15, 2021Break; Break
IT WAS REPORTED THAT PATIENT PACK HAD A BROKEN CONTROLLER HOLSTER AND A BROKEN BATTERY HOLSTER. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11676089 ↗MalfunctionApr 14, 2021Material Split, Cut or Torn; Device Fell; Material Split, Cut or Torn; Device Fell
IT WAS REPORTED THAT THE PATIENT PACK HAD TORN PADDING ON THE SHOULDER STRAP AND THAT THE METAL CLIP OF SHOULDER STRAP WAS BENT. IT WAS NOTED THAT THE CONTROLLER DID FALL DUE TO THIS DAMAGED PATIENT PACK, THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11663881 ↗MalfunctionApr 6, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE BACK PART OF THE PATIENT PACK WAS TORN. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11622070 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK HAD STITCHING THAT WAS COMING APART. IT WAS NOTED THAT THERE WAS A POSSIBILITY THAT BATTERY OR CONTROLLER COULD FALL OUT OF IT¿S INTENDED LOCATION. THE PATIENT PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440067 ↗MalfunctionFeb 4, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT PACK FASTENER CLIP BROKE AS CONTROLLER AND BATTERIES WERE PLACED IN THE PATIENT PACK. THE PATIENT PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11280229 ↗
Other Ventricular (Assisst) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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