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Class 1 Device Recall Impella RP Flex with SmartAssist |
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| Date Initiated by Firm |
June 29, 2023 |
| Date Posted |
August 03, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2281-2023 |
| Recall Event ID |
92411 |
| Product Classification |
Temporary non-roller type right heart support blood pump - Product Code PYX
|
| Product |
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 |
| Code Information |
UDI-DI: 00813502012811;
Serial Numbers: 409541
409542
409544
411379
416645
416646
416647
416649
418933
418939
418940
419489
421953
421955
422974
422978
423999
425596
428726
428730
429616
429617
429623
429646
429648
429649
429650
429651
429652
429654
430363
430365
430366
430367
430923
430929
430931
431099
431106
431532
431535
431844
431846
431847
431848
431850
431868
431869
431870
432394
432395
432396
432397
432398
432400
432401
432402
432643
432644
432645
432648
432651
433755
433756
434540 |
Recalling Firm/
Manufacturer |
Abiomed, Inc.
22 &
24 Cherry Hill Dr
Danvers MA 01923-2575
|
| For Additional Information Contact |
Shashi Thoutam
734-262-6255
|
Manufacturer Reason
for Recall |
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
An URGENT: MEDICAL DEVICE CORRECTION (NOTIFICATION) letter dated 6/29/23 was sent to customers.
RECOMMENDATIONS:
To minimize risk of thrombus formation or deposition, the following is recommended:
" Maintenance of systemic anticoagulation (ACTs of 160-180 seconds) in particular when indwelling central venous lines (i.e., hemodialysis, PA catheters) are present, for the duration of Impella¿ RP Flex with SmartAssist support as clinically feasible.
" Assess the risk for extraluminal thrombus on indwelling lines (i.e., hemodialysis catheters, PA catheters) placed prior to initiation of support.
" Users are reminded of the recommendations included in the best practices pathway on Figure 5.2 of IFU for optimal patient selection. In particular, elements that relate to the risk factors identified above:
o Evidence of end-organ failure (bilirubin >5 or creatinine >4 within 24 hrs of implant)
o Active infection (two of the following three: White Blood Cell (WBC) count >12,500, positive blood culture or fever)
o Documented Deep Vein Thrombosis (DVT)
o Patients on right-sided support or Extracorporeal Membrane Oxygenation (ECMO)
Abiomed is revising the IFUs for the Impella¿ RP Flex with SmartAssist to clarify the risk factors and recommendations related to the potential of thrombus formation or deposition.
ACTIONS TO BE TAKEN BY CUSTOMER/USER
" Product is NOT being removed from the field and does not need to be returned.
" Review, complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to the Recall Coordinator identified in this document. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products).
" If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.
" Post a copy of this notice in a visible area for awareness of this field safety notice.
" Follow th |
| Quantity in Commerce |
166 units |
| Distribution |
US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI. |
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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