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U.S. Department of Health and Human Services

Class 2 Device Recall Impella CP with Smart Assist

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 Class 2 Device Recall Impella CP with Smart Assistsee related information
Date Initiated by FirmSeptember 04, 2019
Create DateNovember 07, 2019
Recall Status1 Terminated 3 on January 21, 2020
Recall NumberZ-0345-2020
Recall Event ID 84025
PMA NumberP140003 
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
Productlmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Code Information UDI: (01)00813502011371(10)1430951(17)210331(21)192148A;  Serial Number: 192148A
FEI Number 1220648
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information ContactRalph Barisano
978-882-8068
Manufacturer Reason
for Recall		This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe affected device was retrieved from the only customer on 9/4/19. An Urgent Medical Device Recall notification letter dated 9/12/19 was sent to that customer as well.
Quantity in Commerce1
DistributionThe product was distributed to GA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = OZD
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