Date Initiated by Firm |
September 04, 2019 |
Create Date |
November 07, 2019 |
Recall Status1 |
Terminated 3 on January 21, 2020 |
Recall Number |
Z-0345-2020 |
Recall Event ID |
84025 |
PMA Number |
P140003 |
Product Classification |
Temporary non-roller type left heart support blood pump - Product Code OZD
|
Product |
lmpella 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 |
Recalling Firm/ Manufacturer |
Abiomed, Inc. 22 Cherry Hill Dr Danvers MA 01923-2575
|
For Additional Information Contact |
Ralph 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 |
Action |
The 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 Commerce |
1 |
Distribution |
The product was distributed to GA |
Total Product Life Cycle |
TPLC Device Report
|
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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 Database |
PMAs with Product Code = OZD and Original Applicant = ABIOMED, INC.
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