Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

FDA device recall Z-2281-2023 · posted 2023-08-03 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PYX

Quantity affected

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.

Date initiated

2023-06-29

Date posted

2023-08-03

Location

Danvers, MA