Reported May 20, 2015 · Ongoing
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline…
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?
- HeartWare Ventricular Assist System (HVAD)
- Pump Driveline Splice Kit Product UsageIs intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side)
- Lot codes and dates
- Catalog #:
- ASY00116HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #:
- ASY00281
HVAD Pump Driveline SplicekitLarge OD Sheath Lot #'s 654090672401678800690423833963873159and 880816
- Amount recalled
- 35
Where it was sold
Why it was recalled
Stop using this product now
Failures of the splice repair kit if exposed to excessive force.
Using this product could cause serious injury, illness or death — stop using it now.
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