PlainRecalls

Maquet Datascope Corp - Cardiac Assist Division

Compiled from official public sources by the editorial team.

14 recalls on record · Latest: Nov 7, 2018

Maquet Datascope Corp - Cardiac Assist Division Recall Insight

Maquet Datascope Corp - Cardiac Assist Division appears on 14 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.014% 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 Nov 7, 2018, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 14 entries, severity tagging shows 10 critical, 4 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 14 of 14 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 (14). The date window on this page runs from May 28, 2014 to Nov 7, 2018.

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 Critical Nov 7, 2018

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

FDA Devices Critical Nov 7, 2018

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

FDA Devices Critical Jun 6, 2018

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-…

FDA Devices Critical Sep 13, 2017

CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coro…

FDA Devices Critical Sep 13, 2017

CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Cor…

FDA Devices Critical Sep 13, 2017

CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coro…

FDA Devices Critical Aug 2, 2017

CS 300 Intra-Aortic Balloon Pump

FDA Devices Critical Aug 2, 2017

CS 100i Intra-Aortic Balloon Pump

FDA Devices Critical Aug 2, 2017

CS 100 Intra-Aortic Balloon Pump

FDA Devices Moderate Mar 8, 2017

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 …

FDA Devices Moderate Apr 6, 2016

Cardiosave Hybrid and rescue IABP

FDA Devices Moderate Mar 4, 2015

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

FDA Devices Moderate Feb 18, 2015

CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demo…

FDA Devices Critical May 28, 2014

Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Maquet Datascope Corp - Cardiac Assist Division with Zimmer Biomet, Inc. →

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.