The U.S. Food and Drug Administration posted a Class 1 device recall, Z-0208-2027, on October 28, 2026. It covers the Automated Impella Controller, which the record describes as the "Primary user control interface for the Impella Catheter, catheter-based heart pump." The recalling firm and manufacturer is Abiomed, Inc., which initiated the recall on September 18, 2026. The record's status is open and classified, and the cause the FDA determined is "Under Investigation by firm". Parts of the record follow, not the whole.
Hardware, Firmware and Software
The manufacturer's reason for the recall says the problems were found by a "Retrospective review of servicing records", which "identified AIC units requiring various hardware, firmware, and/or software update(s)". The record numbers four issues.
The first is an RFID firmware issue that may cause the controller to fail to recognize the purge cassette during case setup or a cassette change, which may delay a procedure or therapy. The second is a potential for the rotary push button to stick and actuate unreliably, which "can result in loss of control of the console." The third is potential instability of the controller that could result in start-up failure, inability to drive the pump, and the need for console exchange.
The fourth is a software defect. "Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations."
The record puts a crash and negative values in the same line. It does not say whether anything warned the user that the calculation had failed.
The Recall Letter, the Units and the Record's Status
Abiomed notified consignees on about September 18, 2026 with an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" letter. The record says consignees were told "that affected units can continue to be used while awaiting service from Abiomed to ensure continuity of care." They were asked to identify affected units on hand, and Abiomed will contact each consignee to coordinate the removal, update and return of the devices.
The quantity in commerce is 428 units, and the record gives the distribution as "Worldwide". A footnote explains that the record's status means the manufacturer "has initiated the recall and not all products have been corrected or removed." Another adds that "Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall."
Sources
- U.S. Food and Drug Administration. Class 1 Device Recall: Automated Impella Controller (recall number Z-0208-2027). 28 October 2026. safety notice