Agency classClass IIOur severity:High FDA (Devices)·Z-1572-2013·Announced 2013-07-03

Maquet Pediatric Arterial Cannula Recalled for Incorrectly Sized Connectors

Maquet is recalling specific pediatric arterial cannula packs because they may contain incorrectly sized connectors. The recall affects 100 units distributed in the US and internationally.

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 3/5 (High).

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 is classified as FDA Class II, and the hazard involves a structural defect (incorrectly sized connector) in a medical device used for critical procedures. No injuries or illnesses are reported in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling specific lots of Maquet Pediatric Arterial Cannula Packs. The recall is issued because the specified parts and lots may contain an incorrectly sized connector. These devices are used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.

The recall involves 100 units, with 60 distributed domestically and 40 internationally. US distribution included Delaware, Illinois, Minnesota, New York, Ohio, and Pennsylvania. International distribution included Germany, Turkey, and France. The affected catalogue numbers, part numbers, and lot numbers are: (1) 161410 (10 FR.): 701022682: 92056588; (2) 163610 (10 Fr): 70102597: 92059789; (3) 163608 (8 Fr.): 70102.2681: 92065640; and (4) 163606 (6 Fr.): 70102.2680: 92063566.

Healthcare providers and facilities should check their inventory for these specific part and lot numbers. If the affected devices are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not specify a direct action for individual consumers, as these are medical devices used in clinical settings.

The recalled product

Product: MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Category: Medical Device — Surgical/Interventional
Hazard: structural-defect
connector-mismatch

Distribution

Distributed in 6 states:

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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