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Boston Scientific De Costa Rica SRL FDA Record

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

Latest inspection VAI · Jun 2, 2022
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Boston Scientific De Costa Rica SRL has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boston Scientific De Costa Rica SRL" is on file.

What these totals cover: FDA records filed under the name "Boston Scientific De Costa Rica SRL" and its spelling variant "Boston Scientific De Costa Rica". 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 inspection: Jun 2, 2022 · VAI

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	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	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 Boston Scientific De Costa Rica SRL 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)
Cardiac Science Corporation Combines 2 spellings Cardiac Science Corporation: 2 recalls, 10 510(k)s, 3 inspections Cardiac Science: 11 510(k)s	Same company group	2	21	3	0	Jun 4, 2019 (Z-1938-2019)
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	—
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 FDA inspections

7 inspections from Oct 6, 2010 to Jun 2, 2022.

Date	Site	Product	Classification	FEI
Jun 2, 2022	El Coyol, Costa Rica	Devices	Voluntary Action Indicated (VAI)	3007695959
May 12, 2016	El Coyol, Costa Rica	Devices	No Action Indicated (NAI)	3007695959
Jan 8, 2016	Heredia, Costa Rica	Devices	No Action Indicated (NAI)	3004859241
Jan 23, 2014	El Coyol, Costa Rica	Devices	No Action Indicated (NAI)	3007695959
Dec 19, 2013	Heredia, Costa Rica	Devices	No Action Indicated (NAI)	3004859241
Sep 13, 2012	Heredia, Costa Rica	Devices	No Action Indicated (NAI)	3004859241
Oct 6, 2010	Heredia, Costa Rica	Devices	No Action Indicated (NAI)	3004859241

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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007695959	El Coyol, Costa Rica	3	Jun 2, 2022
FEI 3004859241	Heredia, Costa Rica	4	Jan 8, 2016

Boston Scientific De Costa Rica SRL and the FDA: common questions

Has Boston Scientific De Costa Rica SRL received an FDA warning letter?

No FDA warning letter addressed to the name "Boston Scientific De Costa Rica SRL" 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 Boston Scientific De Costa Rica SRL received an FDA Form 483?

FDA has not published a Form 483 for "Boston Scientific De Costa Rica SRL" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Boston Scientific De Costa Rica SRL?

The most recent FDA inspection on file ended Jun 2, 2022 at El Coyol, Costa Rica and was classified VAI. FDA has 7 inspections of Boston Scientific De Costa Rica SRL on file.

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