Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Maquet Cardiovascular: medical device reports filed with FDA

20,227 reports name it as the manufacturer of the device involved, 2008–2026.

20,227
reports naming it as manufacturer
0.1% of all MAUDE reports
1,116
reports, 12 months to August 2026
1,423 in the 12 months before
90.2%
classified as malfunction
62.3% across all reports
0.2%
classified as death, as reported
0.9% across all reports

20,227 medical device reports received by FDA give Maquet Cardiovascular as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,116 reports arrived in the 12 months to August 2026, down 22% from 1,423 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (90.2%), injury (9.5%) and death (0.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

BrandDevice typeReportsLatest 12 monthsClassified as death
VasoView Hemopro 2Electrosurgical, cutting & coagulation & accessories5,3226860%
Vaso View HemoproElectrosurgical, cutting & coagulation & accessories1,00000.1%
Vasoview HemoproElectrosurgical, cutting & coagulation & accessories95500%
Vasoview Hemopro Endoscopic Vessel Harvesting SystemElectrosurgical, cutting & coagulation & accessories51200%
T.W. Power SupplyUnit, cautery, thermal, ac-powered5041150%
Vasoviewhempro Vh-3500Electrosurgical, cutting & coagulation & accessories37800%
Vasoview Hemopro Evh SystemElectrosurgical, cutting & coagulation & accessories37100%
HemoPro2 Extension CableElectrosurgical, cutting & coagulation & accessories355300%
Acrobat-i StabilizerStabilizer, heart299370.2%
7mm Extended Length EndoscopeLaparoscope, general & plastic surgery285300%
Vasoview Hemopro Tissue WelderElectrosurgical, cutting & coagulation & accessories28000%
Vasoview 7 XbElectrosurgical, cutting & coagulation & accessories27300%
Vasoview Hemopro 2 Evh SystemElectrosurgical, cutting & coagulation & accessories25800%
Vasoview Endoscopic Vessel Harvesting System 6Electrosurgical, cutting & coagulation & accessories25100%
Vasoview 7xb Endoscopic Vessel Harvesting SystemLaparoscope, general & plastic surgery23800%
Vasoview 6 ProElectrosurgical, cutting & coagulation & accessories22680%
Dc Extension CableElectrosurgical, cutting & coagulation & accessories19400%
Vasoview 6 Evh SystemElectrosurgical, cutting & coagulation & accessories14800%
Hemopro2 AdaptorElectrosurgical, cutting & coagulation & accessories103140%
Vasoview Hemopro 2 With VasoshieldElectrosurgical, cutting & coagulation & accessories7300%
Bom 7mm Extended Length EndoscopeLaparoscope, general & plastic surgery6200%
Custom Tubing PackTubing, pump, cardiopulmonary bypass103531.1%
Hemashield Microvel Double Velour GraftGraft, vascular, synthetic/biologic composite906.4%
NiSet, administration, for peritoneal dialysis, disposable31,5871.8%
Servo-IVentilator, continuous, facility use331.3%
Compressor MiniCompressor, air, portable100.1%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product codeDevice typeReportsShare
GEIElectrosurgical, cutting & coagulation & accessories12,32160.9%
DXCClamp, vascular5,16425.5%
GCJLaparoscope, general & plastic surgery9584.7%
HQOUnit, cautery, thermal, ac-powered6883.4%
MWSStabilizer, heart4822.4%
DWSInstruments, surgical, cardiovascular1380.7%
DSYProsthesis, vascular graft, of 6mm and greater diameter1300.6%
MALGraft, vascular, synthetic/biologic composite1120.6%
FQHLavage, jet540.3%
DSPSystem, balloon, intra-aortic and control360.2%

Reports by month, five years

090179Sep 2021: 69Oct 2021: 99Nov 2021: 109Dec 2021: 942022Jan 2022: 93Feb 2022: 99Mar 2022: 81Apr 2022: 93May 2022: 95Jun 2022: 130Jul 2022: 47Aug 2022: 100Sep 2022: 81Oct 2022: 71Nov 2022: 87Dec 2022: 512023Jan 2023: 75Feb 2023: 93Mar 2023: 83Apr 2023: 92May 2023: 102Jun 2023: 70Jul 2023: 116Aug 2023: 87Sep 2023: 96Oct 2023: 78Nov 2023: 93Dec 2023: 922024Jan 2024: 77Feb 2024: 82Mar 2024: 149Apr 2024: 148May 2024: 179Jun 2024: 119Jul 2024: 121Aug 2024: 126Sep 2024: 84Oct 2024: 129Nov 2024: 119Dec 2024: 922025Jan 2025: 99Feb 2025: 125Mar 2025: 170Apr 2025: 119May 2025: 133Jun 2025: 126Jul 2025: 143Aug 2025: 84Sep 2025: 106Oct 2025: 78Nov 2025: 80Dec 2025: 852026Jan 2026: 40Feb 2026: 88Mar 2026: 118Apr 2026: 88May 2026: 106Jun 2026: 114Jul 2026: 105Aug 2026: 108

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.2%33
Injury9.5%1,920
Malfunction90.2%18,244
Other0%7
Not given0.1%23

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Maquet Cardiovascular reports

How many FDA device reports name Maquet Cardiovascular as manufacturer?

20,227 reports through August 2026, 1,116 of them in the latest 12 months.

Which of its brands appear most often?

VasoView Hemopro 2 (5,322), Vaso View Hemopro (1,000), Vasoview Hemopro (955), Vasoview Hemopro Endoscopic Vessel Harvesting System (512) and T.W. Power Supply (504).

Which device types does it report on?

electrosurgical, cutting & coagulation & accessories (60.9%), clamp, vascular (25.5%), laparoscope, general & plastic surgery (4.7%) and unit, cautery, thermal, ac-powered (3.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.