Maquet Pediatric Arterial Cannula Recall for Limited Flexibility
Maquet Inc. is recalling certain pediatric arterial cannulas because the hardened tip may be too long, limiting flexibility during extracorporeal circulation procedures.
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 involves a medical device with a functional defect (limited flexibility) that poses a risk of harm during a procedure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Inc. is recalling specific lots of the Maquet Getinge Group Pediatric Arterial Cannula. The recall involves 20 devices in the United States and 122 devices distributed internationally. These devices are used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures.
The recall is being issued because certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip. The affected products include Catalog Number 161412 with Batch Number 92048923 and Batch Number 92051578.
The devices were distributed worldwide, including in the United States (specifically Michigan and Minnesota) and internationally. Healthcare providers should stop using the affected devices and contact Maquet Inc. for further instructions.
The recalled product
- Product
- Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during…
- Manufacturer
- Maquet Inc.
- Category
- Medical Device — Cardiopulmonary
Distribution
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