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Cardiac Science Corporation FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Nov 3, 2016
No warning letters matched by name

Inspections 3

0 OAI

Recalls 2

0 Class I (0%)

Warning letters 0 None on file

510(k) clearances 21 Latest May 4, 2015

Cardiac Science Corporation has 2 FDA recalls, 3 inspections, 21 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cardiac Science Corporation" is on file.

What these totals cover: FDA records filed under the name "Cardiac Science Corporation" and its spelling variant "Cardiac Science". Records filed under related names are not included; see Related names.

Latest recall: Z-0311-2027 · Sep 30, 2026 · filed under Boston Scientific Neuromodulation Corporation
Latest recall under this name: Z-1938-2019 · Class II · Jun 4, 2019
Latest inspection: Nov 3, 2016 · NAI
Latest 510(k): May 4, 2015

Newer recall under related name Boston Scientific Neuromodulation Corporation: Sep 30, 2026, Z-0311-2027.

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	2	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	21	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Cardiac Science Corporation above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Boston Scientific Neuromodulation Corporation Combines 2 spellings Boston Scientific Neuromodulation Corporation: 25 recalls, 1 510(k), 8 inspections Boston Scientific Neuromodulation: 9 510(k)s	Same company group	25	10	8	0	Sep 30, 2026 (Z-0311-2027)
Boston Scientific Corporation Combines 3 spellings Boston Scientific Corporation: 642 recalls, 239 510(k)s, 84 inspections, 1 compliance action Boston Scientific: 19 recalls, 494 510(k)s, 15 inspections Boston Scientific Limited: 1 510(k), 6 inspections	Same company group	661	734	105	1	Sep 10, 2026 (Z-0143-2027)
Baylis Medical Company Combines 3 spellings Baylis Medical Company: 3 recalls, 24 510(k)s Baylis Medical: 1 510(k) Baylis Medical Co: 28 510(k)s, 1 inspection	Same company group	3	53	1	0	Oct 7, 2019 (Z-2070-2020)
Endochoice	Same company group	1	27	0	0	Dec 18, 2015 (Z-0694-2016)
American Medical Systems	Same company group	6	82	0	0	Oct 15, 2014 (Z-0806-2015)
Guidant Combines 2 spellings Guidant: 71 510(k)s Guidant Corporation: 15 510(k)s	Same company group	0	86	0	0	—
Boston Scientific Scimed	Same company group	0	35	0	0	—
Boston Scientific De Costa Rica	Same company group	0	0	7	0	—
Btg International	Same company group	0	6	1	0	—
Endochoice Wcdc	Same company group	0	0	2	0	—
Boston Scientific Cardiac Diagnostic Technologies	Same company group	0	1	0	0	—
Endochoice Scope Services	Same company group	0	0	1	0	—

Recent recalls

2 recall records from Jan 14, 2016 to Jun 4, 2019.

Number	Class	Product	Date
Z-1938-2019	Class II	Powerheart¿ G5 Automatic AED	Jun 4, 2019
Z-0829-2016	Class II	9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P…	Jan 14, 2016

Recent FDA inspections

3 inspections from Mar 22, 2010 to Nov 3, 2016.

Date	Site	Product	Classification	FEI
Nov 3, 2016	Laguna Hills, CA	Devices	No Action Indicated (NAI)	3004495806
Apr 25, 2013	Laguna Hills, CA	Devices	No Action Indicated (NAI)	3004495806
Mar 22, 2010	Laguna Hills, CA	Devices	No Action Indicated (NAI)	3004495806

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3004495806	Laguna Hills, CA	3	Nov 3, 2016

Recent 510(k) clearances

21 510(k) clearances from Oct 16, 1997 to May 4, 2015. Showing the 20 most recent. View all 21 510(k) clearances

K-Number	Device	Date
K143714	Powerheart G5 AED	May 4, 2015
K122758	POWERHEART G5 AED	Feb 12, 2014
K113176	MYSENSE HEART	Dec 21, 2011
K102496	POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED…	Jun 9, 2011
K093211	CARECENTER MD	Jun 3, 2010
K091943	POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A	Sep 10, 2009
K082090	9131 DEFIBRILLATION ELECTRODES	Dec 12, 2008
K082173	Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S	Aug 26, 2008
K060934	MODIFICATION TO POWERHEART ECD	May 15, 2006
K060167	ATRIA 3100, ATRIA 6100	Apr 19, 2006
K052316	POWERHEART ECD	Jan 3, 2006
K052161	POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)	Oct 21, 2005
K040637	POWERHEART AED G3 PRO	Aug 6, 2004
K040438	POWERHEART AED G3A	Jul 1, 2004
K031987	POWERHEART AED G3, MODEL 9300	Jul 30, 2003
K022929	PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210	Jan 27, 2003
K022210	MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650	Oct 4, 2002
K012197	POWERHEART CARDIAC RHYTHM MODULE	Nov 16, 2001
K993533	POWERHEART AECD	Jan 24, 2000
K982710	AECD ARRHYTHMIA DETECTION SOFTWARE	Aug 10, 1998

Cardiac Science Corporation and the FDA: common questions

Has Cardiac Science Corporation received an FDA warning letter?

No FDA warning letter addressed to the name "Cardiac Science Corporation" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Cardiac Science Corporation received an FDA Form 483?

FDA has not published a Form 483 for "Cardiac Science Corporation" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Cardiac Science Corporation?

The most recent FDA inspection on file ended Nov 3, 2016 at Laguna Hills, CA and was classified NAI. FDA has 3 inspections of Cardiac Science Corporation on file.

Has Cardiac Science Corporation had an FDA recall?

Yes. Cardiac Science Corporation has 2 FDA recalls on record. The most recent under this name started Jun 4, 2019. A newer recall, dated Sep 30, 2026, is filed under the related name Boston Scientific Neuromodulation Corporation.

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