NA Conv.kitRecalls & reported problems
Maquet Cardiopulmonary AG · Conv.kit 11000, HMO30000/31000/10000/11000 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 18, 2020Terminated
Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
Z-2780-2020 · Root cause: Under Investigation by firm · FDA record ↗
Other ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS devices
- LifeSPARC 5800-1000Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass1 recall1 death9 reports
- NA INFUSION POLEMaquet Cardiopulmonary AG · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 recall0 reports
- TandemLife LifeSPARC 5840-2415Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass1 recall0 reports
- LifeSPARC 5800-0000Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass2 reports
- CentriMag™ 201-50112Thoratec Corporation · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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