Abiomed, Inc. recalls Impella Optical Controller

Recalling company

Abiomed, Inc.

Product

Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.

Reason

Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console. 3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange. 4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Sep 18, 2026

Reported

Nov 4, 2026

Distribution

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries: Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom

Status

Ongoing

Quantity

179 units

Lot / codes

Product Code: 0042-0010-US, 0042-0010-UK, 0042-0010-EU, 0042-0010-IN; UDI: 00813502010985, 00813502010978, 00813502010961, 00813502011425; Serial No. IC6962, IC7004, IC7036, IC7170, IC7213, IC7214, IC7239, IC7241, IC7677, IC7787, IC7880, IC8105, IC8106, IC8295, IC8308, IC8315, IC8316, IC8335, IC8541, IC8543, IC11456, IC7937, IC9832, IC9833, IC5409, IC7798, IC7800, IC7946, IC8070, IC8337, IC8441, IC7825, IC8126, IC8630, IC8640, IC9804, IC11451, IC11497, IC8388, IC8751, IC9501, IC9989, IC10102, IC10103, IC10318, IC10589, IC10463, IC10979, IC11299, IC8164, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC13231, IC13263, IC13264, IC13265, IC13681, IC13682, IC10040, IC10043, IC8401, IC8748, IC8980, IC8609, IC9178, IC9177, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970, IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8333, IC8494, IC12326, IC4952, IC5041, IC5158, IC5281, IC5283, IC5284, IC5403, IC5404, IC5413, IC5527, IC5588, IC5635, IC5636, IC5641, IC5643, IC5666, IC5667, IC5804, IC5805, IC5918, IC5921, IC6013, IC6343, IC6421, IC6422, IC6461, IC6463, IC6465, IC6777, IC6785, IC6944, IC6945, IC6946, IC7161, IC7233, IC7232, IC7235, IC7626, IC7738, IC7739, IC7792, IC7793, IC7826, IC7956, IC8012, IC8258, IC8423, IC8424, IC8499, IC8511, IC8723, IC8596, IC86

Company location

Danvers, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-0209-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0209-2027 in the FDA Enforcement Report. Also see FDA recall press releases.