Reported Feb 10, 2021 · Ongoing
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101,…
Heartware, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- Medtronic HVAD Pump Implant Kits
- labeled as
a. PUMP 1103b. PUMP 1104c. PUMP 1104JPd. PUMP 1100e. Model 1101f. Model 1102g. Model 1104CA-CLINh. Model 1205i. Model MCS1705PU
- Lot codes and dates
- a
- Model Number 1103
520 of 520 codes
GTIN 00888707003261Serial Numbers HW40002HW40004HW40006HW40009HW40017HW40025HW40045HW40046HW40048HW40049HW40051HW40054HW40061HW40067HW40068HW40073HW40074HW40075HW40079HW40085HW40087HW40089HW40090HW40094HW40097HW40099HW40100HW40109HW40112HW40120HW40121HW40122HW40138HW40139HW40143HW40145HW40147HW40149HW40152HW40153HW40154HW40157HW40166HW40168HW40169HW40176HW40177HW40178HW40186HW40189HW40190HW40192HW40197HW40199HW40200HW40201HW40202HW40206HW40209
- Serial Numbers
1,301 of 1,301 codes
HW29766HW29809HW29831HW29874HW29946HW30015HW31099HW31169HW31174HW31177HW31181HW31189HW31215HW31246HW31278HW31279HW31281HW31289HW31302HW31313HW31347HW31349HW31361HW31363HW31369HW31389HW31401HW31480HW31498HW31535HW31542HW31567HW31568HW31575HW31576HW31591HW31595HW31599HW31606HW31608HW31609HW31612HW31613HW31615HW31617HW31624HW31634HW31643HW31647HW31648HW31649HW31652HW31653HW31671HW31677HW31689HW31690HW31692HW31695HW31705
- Serial Numbers
1,803 of 1,803 codes
HW10991HW11011HW11012HW11013HW11017HW11019HW11020HW11022HW11023HW11024HW11026HW11030HW11032HW11033HW11034HW11035HW11036HW11037HW11038HW11040HW11042HW11043HW11044HW11046HW11047HW11050HW11051HW11052HW11053HW11054HW11057HW11060HW11061HW11062HW11063HW11064HW11065HW11067HW11070HW11071HW11072HW11074HW11075HW11076HW11077HW11078HW11082HW11083HW11085HW11086HW11087HW11088HW11089HW11091HW11092HW11093HW11094HW11096HW11100HW11101
- Amount recalled
- 19,562 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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