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Maquet Cardiopulmonary Gmbh FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);Class IIJul 31, 2026The packaging may not consistently maintain sterile barrier |
| Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);Class IIJul 31, 2026The packaging may not consistently maintain sterile barrier |
| Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);Class IIJul 31, 2026The packaging may not consistently maintain sterile barrier |
| Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;Class IIJan 9, 2026Internal investigations have identified an issue with the du |
| Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.Class IIJun 27, 2025Device does not comply with the labeling requirements of int |