Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Defect
Maquet is recalling Aortic Arterial Cannulas because de-airing plugs may break during removal. The defect could compromise the device's integrity during cardiopulmonary bypass.
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 high-risk medical device used in life-support procedures (cardiopulmonary bypass) where a mechanical defect could lead to serious injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas (Part Number 701002246, Article Number A22-7107) used in cardiopulmonary bypass. The recall involves 470 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall is issued because the 3/8-width de-airing plugs supplied with these cannulas may break during the process of removal from the arterial cannula. This defect poses a risk to the integrity of the medical device during use.
Healthcare facilities and distributors should stop using the affected lots (92181729 and 92181287) and contact Maquet Cardiopulmonary Ag for instructions on return or replacement. Patients who have had these devices implanted should consult their healthcare provider for guidance.
The recalled product
- Product
- Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
- Manufacturer
- Maquet Cardiopulmonary Ag
- Affected units
- 470
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 (2)
- UDI CODE: 04037691123813
- Lot Number: 92181729 and 92181287
Distribution
Part of a larger recall action
This product is one of 3 recalled by Maquet Cardiopulmonary Ag under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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