Advocacy

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for nearly 14,000 Abbott and Thoratec HeartMate left ventricular assist devices (LVADs). This recall comes after reports of multiple deaths and injuries associated with these devices, which are used to aid patients with advanced heart failure. 

The recalled devices include: 

• Product names: HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) 
• Product codes: DSQ 
  • Class 1 Device Recall HeartMate II Left Ventricular Assist System (fda.gov) 
  • Class 1 Device Recall HeartMate 3 Left Ventricular Assist System (fda.gov) 
• Model numbers:  Full List of Affected Devices 
• Distribution dates: Starting April 21, 2008 

The problem at the center of this recall is the gradual buildup of biological material in these devices develops over 2 or more years, potentially obstructing the device and diminishing its ability to support the heart's pumping action. This issue can trigger alarms for low blood flow and impair the device's effectiveness. 

Recall Action: This recall is classified as a correction rather than a complete product withdrawal. The FDA has not advised the return of all affected devices. However, heightened vigilance concerning low-flow alarms, which may indicate significant outflow obstructions, is recommended. 

Customers should have received an Urgent Medical Device Correction letter on February 19, 2024, providing detailed guidance on monitoring for and addressing potential obstructions. 

Abbott and Thoratec have made efforts to educate physicians on the importance of heeding persistent low-flow alarms as early indicators of potential obstructions and have shared diagnostic recommendations to identify obstructions and discussed treatment options available for managing such issues.  

If you have questions about this recall, contact Abbott and Thoratec directly at (844) 692-6367. To report a problem with these devices, complete the FDA reporting form

Abiomed is recalling the instructions for use of its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. The FDA has identified this as a Class I recall-- the most urgent type of recall-- where use of or exposure to a violative product will cause serious adverse health consequences or death. 

The recalled devices include: 

• US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist ; Impella LD 
• Product Codes:  See Recall Database Entry 
• Distribution Dates: October 10, 2021 to October 10, 2023 

During operations, the recalled Impella device could cut through the wall of the left ventricle. Use of the pumps could cause left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. The FDA stated that there have been 129 reported serious injuries, including 49 reports of death. 

Customers of Impella devices should have received an Urgent Medical Device Correction letter from Abiomed on December 27, 2023. The letter requested customers adhere to the following new and revised warnings: 

• Carefully position the pump catheter during operative procedures 
• Use imaging when advancing or torquing the pump catheter 
• Use special care when inserting the pump catheter in patients with certain high-risk conditions or during active CPR 
• Review the updated warnings in the device’s Instructions for Use 
• Notify everyone at your facility who needs to be informed of this recall correction 
• Notify any other facilities where the products have been forwarded the updated Instructions for Use  

If you have questions about this recall, contact Abiomed, Inc. at (978) 646-1400. To report a problem, complete the FDA reporting form. 

The House and Senate just approved a new government funding bill that provides $730 million in relief from Medicare physician payment cuts, boosting reimbursements by 1.68% starting on March 9 and lasting through the end of 2024. 
 
STS has vigorously advocated for this relief, yet the total amount is less than what many stakeholders demanded, including STS, 30 members of the U.S. Senate, and nearly 200 members of the U.S. House of Representatives. We will continue to advocate for the elimination of all payment cuts and insist on systematic reforms that eliminate this threat. This includes H.R. 2474, a bipartisan bill with broad support that would create automatic annual inflation adjustments for Medicare physician payments. Contact Congress on this important issue. 
 
Additional Details

• The relief will apply to services rendered between March 9 and Dec. 31, 2024. 
• After applying the relief, Medicare payments will remain 1.69% lower than in 2023. 
• The payment reduction relief will not apply to claims between Jan. 1 and March 8, 2024. 
• On Jan. 1, 2025, an additional reduction of at least 2.93% will occur, absent congressional action, due to the expiration of temporary relief.

If you have questions, contact advocacy@sts.org.