Abiomed Recalls Impella Connect Optical AIC Units for Hardware and Software Defects
Abiomed is recalling 293 Impella Connect Optical AIC units due to hardware and software defects that may cause pump control issues or inaccurate pressure readings.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death. The source text does not report any illnesses, injuries, or deaths.
Plain-English summary
Abiomed, Inc. is recalling 293 units of the Impella Connect Optical AIC, a primary user control interface for the Impella Catheter, a catheter-based heart pump. The recall was initiated after a retrospective review of servicing records identified units requiring hardware, firmware, or software updates.
The identified issues include an RFID firmware problem that may prevent the device from recognizing the purge cassette, potentially delaying procedures; a rotary push button that may stick, impacting the operator's ability to select menu entries and potentially resulting in loss of control of the console; potential instability that could cause start-up failure or inability to drive the pump; and a software defect that may lead to negative central venous pressure values in pulmonary artery pressure calculations.
The affected units were distributed worldwide, including in the United States and 31 foreign countries. The source text does not report any illnesses, injuries, or deaths associated with these defects.
The recalled product
- Product
- Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 293
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code:0042-0040-US
- 0042-0040-UK
- 0042-0040-EU
- 0042-0040-CA
- UDI: 00813502011401
- 00813502012484
- 00813502012217
- 00813502012958
- Serial No. IC8024
- IC7912
- IC8179
- IC8216
- IC8349
- IC8415
- IC8418
- IC8529
- IC8617
- IC8808
- IC8852
- IC8906
Distribution
Distributed nationwide across the United States.
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