Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits because packaging may not consistently maintain sterile barrier integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the sterile barrier integrity may be compromised, posing a risk of harm (infection) even though no injuries or illnesses have been reported yet. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits (PIK), Guidewire 100 cm, Model Numbers 701053068 (USA) and 701047384 (OUS). The recall involves 68,371 units, including 1,765 units in the US and 66,606 units outside the US. The product was distributed worldwide, including in the United States, Australia, Austria, and other countries.
The recall was initiated because the packaging may not consistently maintain sterile barrier integrity. This defect could potentially compromise the sterility of the medical device. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected Percutaneous Insertion Kits and contact Maquet Cardiopulmonary GmbH for instructions on return or replacement. The recall number is Z-3144-2026.
The recalled product
- Product
- Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
- Manufacturer
- Maquet Cardiopulmonary Gmbh
- Category
- Medical Device — Cardiovascular
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number (USA): 701053068
- UDI-DI: 4037691519883
- Lot Numbers: 3000324477
- 3000333824
- 3000336037
- 3000341450
- 3000343893
- 3000377475
- 3000387891
- 3000403656
- 3000414516
- 3000430803
- 3000441821
- 3000453326
- 3000471523
- 3000476321
- 3000485151
- 3000496204
- 3000510428
- 3000518006
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Maquet Cardiopulmonary Gmbh
See all →- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
- ModerateBubble sensors recalled over connecting cables that can be damaged
FDA (Devices) · 2026-02-11
- ModerateSprinter Cart infusion poles do not meet IEC 60601-1 labeling requirements
FDA (Devices) · 2025-08-06
Same hazard · sterile barrier failure
See all →- HighBlood Culture Kits Recalled Due to Potential Sterile Barrier Compromise
FDA (Devices) · 2026-09-23
- HighDaig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
FDA (Devices) · 2026-05-20
- ModerateB Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall
FDA (Devices) · 2025-05-14
- HighVial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
- HighMedtronic Clearview Blower Mister Model 22120 recalled for potential unsealed sterile packing
FDA (Devices) · 2024-05-22