Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns
Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.
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 risk of compromised sterility, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Datascope Corporation is recalling 676 units of Reinforced Introducer Sets (Maquet 7.5 Fr., Part Number 068400040305) due to a potential for compromised sterility in breached pouches. These sets are accessories used for the percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
The recall covers specific lot codes including 3000040290, 3000086802, 3000031711, 3000079613, 3000019781, 3000053099, 3000014728, 3000043100, and TTQ. The affected products were distributed to 38 states in the United States and 11 countries internationally, including Canada, Germany, and the Netherlands.
Healthcare facilities and distributors should stop using the affected lots and contact Datascope Corporation for further instructions on return or replacement.
The recalled product
- Product
- Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
- Manufacturer
- Datascope Corporation
- Affected units
- 676
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 (8)
- 3000086802
- 3000031711
- 3000079613
- 3000019781
- 3000053099
- 3000014728
- 3000043100
- TTQ.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Datascope Corporation 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Datascope Corporation
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Same hazard · sterility compromise
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- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
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Similar recalls
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- HighDatascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
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- HighArrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect
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