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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3251-2026%22

Class II recall Z-3251-2026: Abiomed, Inc.

Q: How to monitor Class II recall Z-3251-2026: Abiomed, Inc. and peer other records

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Class II recall Z-3251-2026: Abiomed, Inc. (Massachusetts): Abiomed, Inc. Dated 35 days ago, it serves as a historical benchmark. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-3251-2026
Recalling firm	Abiomed, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0
Reason	Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
Quantity	3,322 units
Distribution	Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
Recall initiated	2019-02-19
Reported	2026-09-30
Firm location	Danvers, MA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-30
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Class II recall Z-3251-2026: Abiomed, Inc. and 41 Massachusetts peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Massachusetts FDAPulse records like this one: 41
Timing: Low: older than 30 days
Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 35 days ago.

What is the FDAPulse record for Class II recall Z-3251-2026: Abiomed, Inc. in Massachusetts?

Class II device recall Z-3251-2026 by Abiomed, Inc.: Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) fi

How does Class II recall Z-3251-2026: Abiomed, Inc. compare to other Massachusetts FDAPulse records?

It is 35 days old, still within a typical 45-day follow-up window.

Class II recall Z-3251-2026 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-3251-2026	MA	2026-09-30
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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