FDA designates recall of left-sided blood pumps as class I
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Key takeaways:
- The FDA designated Abiomed’s recall of its instructions for use for its left-sided blood pumps as class I, the most serious type.
- Affected devices may perforate the wall of the left ventricle.
Abiomed has issued a recall of the instructions for use for its left-sided blood pumps, as the pump catheter may perforate the wall of the left ventricle or cause free wall rupture, hypertension, lack of blood flow or death.
The FDA has identified the recall of these devices (Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD) as a class I recall, the most serious type of recall, as use of the device may cause injury or death. The FDA noted that this recall is a correction and not a product removal.
On Dec. 27, 2023, the company sent all affected customers an Urgent Medical Device Correction letter with new and revised warnings.
Thes recall includes 66,390 pumps distributed between Oct. 10, 2021, and Oct. 10, 2023.
There have been 129 reported serious injuries, including 49 deaths related to the issue, according to an alert from the FDA.
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