FDA Classifies Abiomed Impella Kit Recall as Class I
The Food and Drug Administration has classified Abiomed’s recall of select 14 Fr Low Profile Introducer Kits as Class I, the agency’s most serious device-recall category, because continued use could cause serious injury or death.
The FDA added the Class I classification on July 17, 2026, and made minor formatting changes to its communication on July 31. Abiomed began the removal action on May 22 after identifying a higher-than-expected rate of complaints involving thrombus formation during prolonged use.
The recall applies to specified products used with the 10th-generation Impella CP with SmartAssist. It does not cover every Impella device or every commercially available Impella CP generation.
Which products are affected
The FDA lists these affected products:
- 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP — product code 1000434
- 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP — product code 1000435
- Impella CP Set with SmartAssist, 10th Generation — product code 1000413
The FDA notice also lists a 14 Fr x 13 cm and 25 cm Low Profile Introducer Kit for Japan under product code 1000542. Hospitals should compare product labels and inventory with the FDA and Abiomed notices rather than assume that all Impella products are included.
The introducer kit is intended to facilitate access to the vascular system for introduction and removal of the Impella CP with SmartAssist and related devices.
What can go wrong
The reported hazard is thrombus formation during prolonged use of the introducer. The FDA says a thrombus may disrupt blood flow near the access site or become dislodged during support, manipulation or removal. A dislodged thrombus could obstruct a peripheral blood vessel and cause ischemia requiring prompt clinical assessment and intervention.
In less common circumstances, the problem could progress to irreversible vascular occlusion and potential permanent impairment if it is not corrected. The FDA says the cause remains under investigation; the recall record does not establish a final manufacturing root cause.
As of May 15, 2026, Abiomed had reported three serious injuries and no deaths associated with the issue. Those figures are tied to that reporting date and could change as additional information is received.
What hospitals should do
The FDA says affected products should not be used. Facilities should review inventory, quarantine identified units and arrange returns through Sedgwick under Abiomed’s instructions.
Abiomed also instructed customers to notify personnel who manage, transport, store, stock or use the devices. If products were sent to another facility, the receiving facility should be contacted and provided with the company’s notice. The FDA’s recall database lists the action as open and classified.
What the Class I designation means
A Class I designation means the FDA believes continued use of the recalled products could cause serious injury or death. It does not mean that every affected device has malfunctioned or that every patient exposed to one was injured.
What patients should know
The recall is directed primarily at hospitals, clinicians and device-management personnel. Patients who are currently receiving or were recently treated with an Impella device should not assume that the recall applies to their device. The FDA says other commercially available generations of Impella CP are not involved.
Patients with questions should contact their treating clinician or the hospital that provided care rather than trying to identify or manage a device themselves.
What to watch next
Hospitals and clinicians should watch for updated FDA or Abiomed instructions, additional injury reports, a change in the recall’s open status and any final determination about the cause of the problem.
Sources
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