Datascope Corporation LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group Recall
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Brand
Datascope Corporation
Lot Codes / Batch Numbers
Part Number - 0684-00-0480-01U
Products Sold
Part Number - 0684-00-0480-01U
Datascope Corporation is recalling LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group due to During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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Page updated: Jan 10, 2026