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Serious riskFDA DeviceClass I

Abiomed Impella controller recalled for console control defects

Abiomed is recalling 179 Impella Optical Controllers, the control unit for the Impella heart pump, after reviewing service records. The units may need hardware, firmware, or software updates to fix problems that could delay therapy, make menu buttons unreliable, or cause the controller to fail to start. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Abiomed recalls

What to do

  1. Check whether your controller's serial number is on the recall list.
  2. Contact Abiomed for the required hardware, firmware, or software update.
  3. Ask your hospital or clinical team to confirm the controller is updated before use.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Sold in
Nationwide
Made for
Adults (under 0 months)

This recall covers 3 products — see all of them.

Details

Units affected
179 units
Illnesses reported
None reported
Manufactured in
22 Cherry Hill Dr, Danvers, Massachusetts, United States
Classification
Class I
Recall number
Z-0209-2027

In the FDA's words

Description
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. 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. 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, IC8665, IC8765, IC7827, IC7828, IC8404, IC11746, IC12344, IC12327, IC8426, IC13232, IC13698, IC7861, IC7862, IC8121, IC8222, IC8225. 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 Affected quantity: 179 units
Hazard
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.

3 products in this recall

Abiomed Impella controllers recalled for hardware and software issues

Abiomed is recalling 900 Impella heart pump controllers in three products: Automated Impella Controller, Impella Optical Controller, and Impella Connect Optical AIC. The units need hardware, firmware, or software updates found during a review of servicing records. Possible problems include the controller failing to recognize the purge cassette, a sticking push button that can cause loss of console control, start-up failure, and a software defect that can show incorrect negative pressure readings. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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