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MAQUET CARDIOPULMONARY GmbH FDA Inspection Record

FEI 3009507273 · Inspections, Form 483s, warning letters and import refusals

MAQUET CARDIOPULMONARY GmbH is an FDA-registered facility (FEI 3009507273) located in Rastatt Baden-Wurttemberg, DE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 28, 2022: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Sep 26, 2013
Warning letters
1 listed by FDA for this FEI, latest Dec 4, 2014
Recalls as the recalling firm
6, latest Jul 31, 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

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 28, 2022No Action Indicated (NAI)No citations listed
Sep 26, 2013Official Action Indicated (OAI)No citations listed

Recalls

Newest first. 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
Jul 31, 2026Class IIZ-3144-2026Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA)… and 2 more products
The packaging may not consistently maintain sterile barrier integrity.
Jan 9, 2026Class IIZ-1300-2026Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble…
Jun 27, 2025Class IIZ-2193-2025Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion…
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Apr 30, 2025Class IIZ-1823-2025Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i…
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
May 14, 2018Class IIZ-2159-2018Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number… and 2 more products
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the…
Apr 4, 2018Class IIZ-1642-2018CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product…
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.

FDA record score

18 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. Each record below adds the points shown.

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.

8 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-3144-2026, this FEI as the recalling firmJul 31, 20264 x 14
Class II recall Z-1300-2026, this FEI as the recalling firmJan 9, 20264 x 14
Class II recall Z-2193-2025, this FEI as the recalling firmJun 27, 20254 x 14
Class II recall Z-1823-2025, this FEI as the recalling firmApr 30, 20254 x 14
Class II recall Z-2159-2018, this FEI as the recalling firmMay 14, 20184 x 0.251
Class II recall Z-1642-2018, this FEI as the recalling firmApr 4, 20184 x 0.251
Warning letter on FDA's dashboard, which does not show close-outsDec 4, 201410 years or older, so it adds no points0
Inspection classified OAISep 26, 201310 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
Maquet Cardiopulmonary Gmbh
Location
Rastatt Baden-Wurttemberg (DE)
Source
device

Compliance actions

Import refusals

FDA data resources

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