This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Name: Abiomed Impella CP with SmartAssist
- Unique Device Identifier (UDI)/Product Code: 00813502012279/0048-0003
- Lot: 1798046
- Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363
What to Do
- No further action is needed. All affected devices were reported returned to Abiomed before reaching patient use.
On May 31, 2024, Abiomed sent customers an Urgent Voluntary Medical Device Recall (Removal) letter recommending the following actions:
- Examine inventory to determine if affected product is present.
- Quarantine and do not use subject products.
- Work with the local Abiomed representative to locate, separate, and return affected product for replacement.
- Complete the Business Response Form included with the letter.
- Forward the notice to any relevant facility personnel or others who may have received the product at other facilities.
- Post a notice copy in a visible area for awareness.
Reason for Recall
Abiomed is recalling certain Impella CP with SmartAssist devices after nine pumps in a single lot failed inspection but were inadvertently released to customers. Using affected pumps may lead to unexpected pump stops or release of potentially harmful particulates.
Serious adverse health consequences could result from use of the affected devices, including heart and blood vessel (cardiovascular) complications such as stroke, low blood pressure, damage to red blood cells (hemolysis), bleeding, fluid buildup in the pericardial sac (cardiac tamponade), heart attack (myocardial infarction), the need for additional surgical procedures, or death.
There have been no reported injuries or deaths. None of the recalled devices were used in patient care.
Device Use
The Impella CP with SmartAssist is used for short-term support of the pumping chamber of the heart (ventricle) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI).
Impella CP with SmartAssist is indicated for use when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy.
Impella therapy aims to reduce the work of the heart's left ventricle and provide support for the circulatory system so the heart has time to recover.
Contact Information
Customers with questions should contact Abiomed customer service at (800) 422-8666 option 2, recall@abiomed.com, or by reaching out to local clinical field staff.
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
