Reported Jun 15, 2022 · Ongoing
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Medtronic 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: Medtronic Inc · 710 Medtronic Pkwy Mailstop Ls245 · Minneapolis, MN · 55432-5603
Is this the product you have?
HeartWare HVAD Pump Implant Kita) Model Number 1104JPb) Model Number MCS1705PU
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 0088870700536400763000170967Model Number 1104JP: GTIN: 00763000170967 Serial numbers: HW41784, HW41825, HW41829, HW41849, HW41852, HW41853, HW41863, HW42312, HW42352, HW42775, HW42818, HW42879, HW42882, and HW42884. b) Model Number MCS1705PU: , Serial Numbers: HW42448 and HW42571 00888707007139Serial Numbers: HW42955 and HW42962 00888707009041Serial Numbers HW43483 and HW43484 00888707003070and , Serial number HW42153. - Amount recalled
- 21 pump implant kits
Where it was sold
Why it was recalled
Stop using this product now
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
Using this product could cause serious injury, illness or death — stop using it now.
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