Bubble sensors recalled over connecting cables that can be damaged
Maquet Cardiopulmonary is recalling 3,050 Bubble Sensors because excessive bending of the connecting cable can damage the Venous Bubble Sensor or cause loose cable contact.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequences are device error messages, with no patient harm or reported injury.
Plain-English summary
The Bubble Sensor for 3/8" x 3/32" tubing, model number 701055720, is being recalled by Maquet Cardiopulmonary GmbH.
The record states internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors "Ven. bubble sensor defective" or "Ven. bubble sensor disconnected" on the connected medical device. The record states these errors can occur temporarily when the connecting cable is moved, or permanently if the connection is fully compromised.
The record lists 3,050 units under model 701055720, UDI-DI 04037691816432, and states all units are impacted. Distribution was worldwide, covering the United States nationwide and the countries listed in the enforcement record. The FDA has classified the action as Class II.
The stated consequences in the enforcement record are device error messages, and no injuries are reported. Facilities should follow Maquet's instructions.
The recalled product
- Product
- Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
- Manufacturer
- Maquet Cardiopulmonary Gmbh
- Affected units
- 3,050
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 (3)
- Model Number: 701055720
- UDI-DI: 04037691816432
- Serial Numbers: All units impacted
Distribution
Distributed nationwide across the United States.
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