FDA Class II Medical Devices

Maquet Cardiopulmonary Gmbh: Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Maquet Cardiopulmonary Gmbh · Affected quantity: 68371 units (1765 US, 66606 OUS)

Hazard
The packaging may not consistently maintain sterile barrier integrity.

Details
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;. Recall #Z-3144-2026, initiated 20260731. Voluntary: Firm initiated.

Products affected
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Recall status
Ongoing

Reference: FDA Z-3144-2026 · Issued September 23, 2026 · Class II · Indexed by RecallSweep from the official FDA feed.

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