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Serious riskFDA DeviceClass I

Abiomed Impella Controller recalled over console control risks

Abiomed is recalling about 428 Automated Impella Controllers, the control console for the Impella heart pump. A records review found units that need hardware, firmware, or software updates. Problems include failure to recognize the purge cassette, a rotary button that can stick, possible controller start-up failure, and a software defect that can produce incorrect pressure readings.

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

What to do

  1. Contact Abiomed or your hospital or clinic to check whether your controller's serial number is on the list.
  2. Ask about the update and arrange it through your care team.
  3. Do not change patient care without guidance from your clinical team.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
428 units
Illnesses reported
None reported
Manufactured in
22 Cherry Hill Dr, Danvers, Massachusetts, United States
Classification
Class I
Recall number
Z-0208-2027

In the FDA's words

Description
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, 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: 0042-0000-US, 0042-0000-UK, 0042-0000-EU, 0042-0000-IN, 0042-0000-CA; UDI:00813502010022, 00813502011296, 00813502011289, 00813502011418, 00813502011272; Serial No. IC1014, IC1029, IC1038, IC1043, IC1042, IC1061, IC1075, IC1096, IC1122, IC1190, IC1202, IC1203, IC1224, IC1231, IC1238, IC1269, IC1289, IC1446, IC1612, IC1741, IC1771, IC1852, IC1853, IC1708, IC1964, IC2071, IC2069, IC2154, IC2227, IC2314, IC2315, IC2029, IC2321, IC2428, IC2429, IC2521, IC2561, IC2562, IC2575, IC2664, IC2665, IC2691, IC2692, IC2739, IC2782, IC2840, IC2841, IC2848, IC2891, IC2976, IC2977, IC3009, IC3010, IC3154, IC3155, IC3244, IC3246, IC3342, IC3398, IC3347, IC3351, IC3512, IC3609, IC3714, IC3715, IC3772, IC3773, IC3806, IC3822, IC3823, IC3919, IC3975, IC3976, IC4041, IC4042, IC4045, IC4060, IC4250, IC4259, IC4295, IC4339, IC4616, IC4640, IC4641, IC4708, IC4831, IC4832, IC4884, IC5120, IC5151, IC5201, IC5056, IC5549, IC5605, IC5661, IC5662, IC5598, IC5720, IC5721, IC5745, IC5749, IC5750, IC5828, IC5984, IC6042, IC6321, IC6322, IC6328, IC6329, IC6359, IC6360, IC6403, IC6596, IC6597, IC6622, IC6623, IC6632, IC6637, IC6673, IC6825, IC6846, IC6834, IC6835, IC1387, IC1869, IC1909, IC2277, IC2278, IC2871, IC2872, IC3293, IC3294, IC3295, IC3674, IC3675, IC3784, IC3785, IC4741, IC5219, IC5220, IC5553, IC5911, IC5912, IC5926, IC5927, IC6289, IC6286, IC6287, IC6540, IC6583, IC6584, IC6585, IC6845, IC6925, IC7057, IC7074, IC7073, IC7441, IC7442, IC7591, IC1285, IC1416, IC3719, IC3720, IC3776, IC1825, IC1876, IC2175, IC2857, IC2996, IC3296, IC3486, IC3488, IC3890, IC4055, IC4323, IC4681, IC4682, IC4892, IC4984, IC4987, IC4973, IC5048, IC5421, IC5442, IC5464, IC5494, IC5687, IC5611, IC5722, IC5818, IC6065, IC6536, IC6582, IC6588, IC6589, IC6688, IC6694, IC6706, IC6707, IC6728, IC6738, IC6739, IC6740, IC6877, IC7388, IC7389, IC7390, IC7647, IC7649, IC7651, IC7652, IC7776, IC7777, IC5833, IC7444, IC7445, IC7446, IC7447, IC1284, IC1545, IC2368, IC2989, IC4331, IC4438, IC4856, IC2099, IC2823, IC3668, IC4099, IC4218, IC4611, IC4932, IC5490, IC5493, IC7407, IC7675, IC7686, IC7691, IC7692, IC7721, IC7809, IC3575, IC3576, IC3837, IC4065, IC4066, IC4451, IC4452, IC6330, IC3131, IC3132, IC2234, IC2469, IC3331, IC3669, IC3777, IC3828, IC4150, IC1396, IC1397, IC1724, IC1725, IC3050, IC5755, IC5756, IC3301, IC3302, IC3312, IC4675, IC4676, IC1577, IC1594, IC2877, IC6708, IC6806, IC5184, IC5218, IC7443, IC7585, IC5995, IC5996, IC5997, IC5998, IC5999, IC6001, IC6252, IC6253, IC6254, IC6139, IC6476, IC6477, IC6478, IC6475, IC7079, IC7080, IC7408, IC7409, IC7410, IC7411, IC3174, IC3166, IC3167, IC3213, IC3223, IC3475, IC4441, IC4525, IC5215, IC5910, IC7087, IC1280, IC1283, IC1345, IC1411, IC1398, IC2240, IC2557, IC3017, IC3178, IC3179, IC3322, IC3319, IC3490, IC3660, IC3813, IC4232, IC4237, IC4240, IC4242, IC4469, IC4626, IC4737, IC1586, IC1677, IC2021, IC2206, IC2245, IC3016, IC3049, IC3494, IC4329, IC4358, IC4563, IC4723, IC5757, IC6079, IC6080, IC6431, IC6580, IC6581, IC7719, IC3704, IC3705, IC5055, IC1766, IC5435, IC2451, IC2452, IC2453, IC2459, IC2460, IC2461, IC2449, IC1001, IC1179, IC1346, IC1481, IC1595, IC1715, IC1769, IC1790, IC1791, IC1911, IC1913, IC1912, IC2033, IC2035, IC2687, IC3661, IC3662, IC3802, IC4944, IC5034, IC5821, IC5824, IC6082, IC6083, IC6633, IC6636, IC7695, IC7716, IC9413, IC9414, IC9416, IC2442, IC2444, IC2443, IC2476, IC2477, IC2478, IC2479, IC2471, IC3127, IC3128, IC3129, IC3130, IC3306, IC3307, IC3308, IC3309, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3783, IC3812, IC3888, IC3887, IC4068, IC4069, IC4257, IC4507, IC7578, IC3699, IC3700. 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: 428 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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