Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Impella CP with Smart Assist

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Impella CP with Smart Assist see related information
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
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.
-
-