PlainRecalls

Maquet Cardiovascular, LLC

Compiled from official public sources by the editorial team.

251 recalls on record · Latest: Oct 1, 2025

Maquet Cardiovascular, LLC Recall Insight

Maquet Cardiovascular, LLC appears on 251 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.247% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 1, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Apr 24, 2013 to Jun 5, 2019.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02

FDA Devices Moderate Jun 5, 2019

Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757

FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011

FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071

FDA Devices Moderate Jun 5, 2019

Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006

FDA Devices Moderate Jun 5, 2019

Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack

FDA Devices Moderate Jun 5, 2019

Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428

FDA Devices Moderate Jun 5, 2019

Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32…

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834

FDA Devices Moderate Jun 5, 2019

Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 30300 Material:701052623

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664

FDA Devices Moderate Jun 5, 2019

Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266

FDA Devices Moderate Mar 13, 2019

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

FDA Devices Moderate Mar 22, 2017

VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with…

FDA Devices Moderate Nov 5, 2014

Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access D…

FDA Devices Moderate Dec 18, 2013

Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimal…

FDA Devices Moderate Oct 9, 2013

Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sterno…

FDA Devices Moderate Apr 24, 2013

MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and …

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.