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BOSTON SCIENTIFIC CORPORATION FDA Inspection Record

FEI 3002095335 · Inspections, Form 483s, warning letters and import refusals

BOSTON SCIENTIFIC CORPORATION is an FDA-registered facility (FEI 3002095335) located in Maple Grove, MN, US. RegDataLab tracks 11 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 18, 2025: No Action Indicated (NAI)
Inspections on record
11 (3 VAI, 8 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
48, latest Aug 24, 2026
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 11 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 18, 2025No Action Indicated (NAI)No citations listed
Jul 28, 2022No Action Indicated (NAI)No citations listed
Nov 16, 2018Voluntary Action Indicated (VAI)Sponsors' general responsibilities (21 CFR 812.40)
Sponsor securing investigator compliance (21 CFR 812.46(a))
Sponsor correspondence records inadequate (21 CFR 812.140(b)(1))
Apr 27, 2017No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Oct 22, 2015Voluntary Action Indicated (VAI)No citations listed
Dec 4, 2013No Action Indicated (NAI)No citations listed
Aug 6, 2013No Action Indicated (NAI)No citations listed
Feb 2, 2012Voluntary Action Indicated (VAI)Sponsors' general responsibilities (21 CFR 812.40)
Aug 3, 2011No Action Indicated (NAI)No citations listed
Oct 28, 2010No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 48 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Aug 24, 2026Class IZ-3214-2026Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038…
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact…
Jul 9, 2026Class IZ-2977-2026Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number… and 1 more product
Potential for arterial sheath tip separation or partial tip separation during use.
Jun 19, 2026Class IIZ-2771-2026Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001…
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or…
May 11, 2026Class IIZ-2580-2026Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug…
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Dec 3, 2025Class IIZ-1042-2026Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm…
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA)…
Aug 18, 2025Class IIZ-2550-2025ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material… and 1 more product
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Aug 5, 2025Class IIZ-2533-2025Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011… and 3 more products
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the…
Jul 29, 2025Class IZ-2426-2025WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to… and 10 more products
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive…
Jul 7, 2025Class IZ-2273-2025Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and…
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated…
Mar 24, 2025Class IIZ-1686-2025IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are… and 3 more products
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO…

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Jul 11, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.

FDA record score

100 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. The records below add up to 150.9; the score stops at 100.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

51 records behind this number
RecordDatePoints x age weightAdds
Class I recall Z-3214-2026, this FEI as the recalling firmAug 24, 202615 x 115
Class I recall Z-2977-2026, this FEI as the recalling firmJul 9, 202615 x 115
Class I recall Z-2426-2025, this FEI as the recalling firmJul 29, 202515 x 115
Class I recall Z-2273-2025, this FEI as the recalling firmJul 7, 202515 x 115
Class I recall Z-1638-2024, this FEI as the recalling firmMar 21, 202415 x 0.69
Class I recall Z-1374-2024, this FEI as the recalling firmFeb 20, 202415 x 0.69
Class II recall Z-2771-2026, this FEI as the recalling firmJun 19, 20264 x 14
Class II recall Z-2580-2026, this FEI as the recalling firmMay 11, 20264 x 14
Class II recall Z-1042-2026, this FEI as the recalling firmDec 3, 20254 x 14
Class II recall Z-2550-2025, this FEI as the recalling firmAug 18, 20254 x 14
Class II recall Z-2533-2025, this FEI as the recalling firmAug 5, 20254 x 14
Class II recall Z-1686-2025, this FEI as the recalling firmMar 24, 20254 x 14
Class I recall Z-1591-2021, this FEI as the recalling firmApr 12, 202115 x 0.253.8
Class I recall Z-0728-2021, this FEI as the recalling firmNov 17, 202015 x 0.253.8
Class I recall Z-1555-2020, this FEI as the recalling firmFeb 11, 202015 x 0.253.8
Class II recall Z-0095-2025, this FEI as the recalling firmSep 5, 20244 x 0.62.4
Class II recall Z-3147-2024, this FEI as the recalling firmJul 18, 20244 x 0.62.4
Class II recall Z-1396-2024, this FEI as the recalling firmMar 5, 20244 x 0.62.4
Class II recall Z-1390-2024, this FEI as the recalling firmFeb 20, 20244 x 0.62.4
Class II recall Z-0009-2024, this FEI as the recalling firmJul 27, 20234 x 0.62.4
Class II recall Z-1592-2023, this FEI as the recalling firmApr 5, 20234 x 0.62.4
Class II recall Z-0149-2023, this FEI as the recalling firmOct 13, 20224 x 0.62.4
Class II recall Z-1582-2022, this FEI as the recalling firmAug 9, 20224 x 0.62.4
Class II recall Z-1491-2022, this FEI as the recalling firmMay 25, 20224 x 0.62.4
Class II recall Z-0915-2022, this FEI as the recalling firmMar 8, 20224 x 0.62.4
Inspection classified VAINov 16, 20186 x 0.251.5
Class II recall Z-0381-2022, this FEI as the recalling firmNov 8, 20214 x 0.251
Class II recall Z-2327-2021, this FEI as the recalling firmJul 23, 20214 x 0.251
Class II recall Z-1621-2021, this FEI as the recalling firmApr 21, 20214 x 0.251
Class II recall Z-1429-2021, this FEI as the recalling firmMar 5, 20214 x 0.251
Class II recall Z-0657-2021, this FEI as the recalling firmNov 18, 20204 x 0.251
Class II recall Z-0577-2020, this FEI as the recalling firmOct 24, 20194 x 0.251
Class II recall Z-0852-2019, this FEI as the recalling firmDec 19, 20184 x 0.251
Class II recall Z-2735-2018, this FEI as the recalling firmDec 11, 20174 x 0.251
Class II recall Z-0685-2018, this FEI as the recalling firmNov 6, 20174 x 0.251
Class II recall Z-1922-2017, this FEI as the recalling firmApr 5, 20174 x 0.251
Class II recall Z-2645-2017, this FEI as the recalling firmDec 15, 20164 x 0.251
Class II recall Z-1781-2017, this FEI as the recalling firmDec 13, 20164 x 0.251
Class II recall Z-1370-2016, this FEI as the recalling firmMar 28, 201610 years or older, so it adds no points0
Class I recall Z-1342-2016, this FEI as the recalling firmMar 22, 201610 years or older, so it adds no points0
Class I recall Z-0392-2016, this FEI as the recalling firmNov 19, 201510 years or older, so it adds no points0
Inspection classified VAIOct 22, 201510 years or older, so it adds no points0
Class I recall Z-0211-2016, this FEI as the recalling firmOct 9, 201510 years or older, so it adds no points0
Class II recall Z-2765-2015, this FEI as the recalling firmAug 25, 201510 years or older, so it adds no points0
Class II recall Z-2377-2015, this FEI as the recalling firmJul 31, 201510 years or older, so it adds no points0
Class II recall Z-1336-2015, this FEI as the recalling firmFeb 25, 201510 years or older, so it adds no points0
Class II recall Z-1355-2015, this FEI as the recalling firmFeb 25, 201510 years or older, so it adds no points0
Class II recall Z-1164-2014, this FEI as the recalling firmMar 3, 201410 years or older, so it adds no points0
Class II recall Z-0969-2014, this FEI as the recalling firmFeb 4, 201410 years or older, so it adds no points0
Class II recall Z-2137-2013, this FEI as the recalling firmJul 31, 201310 years or older, so it adds no points0
Inspection classified VAIFeb 2, 201210 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Boston Scientific Corporation
Location
Maple Grove, MN (US)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.