FDA Device recall Z-3150-2026

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Pro…

FDA Device
Class I
ongoing
Published 2026-09-23

On 2026-09-23 the FDA classified a Class I recall of Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Pro… by Abiomed, citing the potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3150-2026
Classification	Class I
Status	ongoing
Initiated	2026-08-12
Published	2026-09-23
Last updated	2026-09-29 05:30 UTC
Company	Abiomed
Distribution	US

Product

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;

Reason

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Identifiers

code_info	1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC… 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC12674, IC12675, IC13066, IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11487, IC11489, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12583, IC12584, IC12804, IC13070, IC13071, IC13085, IC13093, IC13094, IC13095, IC13096, IC13233, IC13234, IC13561, IC13566, IC13749, IC13753; 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA; UDI-DI: 00813502012958; Serial Numbers: IC10306, IC10312, IC11171, IC11172, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC13266, IC13267, IC13503, IC13504, IC13617, IC13618, IC13713, IC13714, IC13715, IC13716, IC13726, IC13801, IC13802; 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU; UDI-DI: 00813502012217 Serial Numbers: IC10382, IC10419, IC10681, IC10683, IC11123, IC11125, IC11257, IC11258, IC11262, IC11264, IC11265, IC11266, IC11282, IC12012,

code_info

1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC…

1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC12674, IC12675, IC13066, IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11487, IC11489, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12583, IC12584, IC12804, IC13070, IC13071, IC13085, IC13093, IC13094, IC13095, IC13096, IC13233, IC13234, IC13561, IC13566, IC13749, IC13753; 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA; UDI-DI: 00813502012958; Serial Numbers: IC10306, IC10312, IC11171, IC11172, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC13266, IC13267, IC13503, IC13504, IC13617, IC13618, IC13713, IC13714, IC13715, IC13716, IC13726, IC13801, IC13802; 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU; UDI-DI: 00813502012217 Serial Numbers: IC10382, IC10419, IC10681, IC10683, IC11123, IC11125, IC11257, IC11258, IC11262, IC11264, IC11265, IC11266, IC11282, IC12012,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.

Other recalls by Abiomed

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA
FDA Device · Class II · 2026-09-30 · Abiomed
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA
FDA Device · Class I · 2026-09-23 · Abiomed
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU
FDA Device · Class I · 2026-09-23 · Abiomed
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Prod…
FDA Device · Class I · 2026-07-22 · Abiomed
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342…
FDA Device · Class I · 2026-07-22 · Abiomed

All Abiomed recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3150-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.