Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns
Datascope is recalling specific lots of Reinforced Introducer Sets due to potential sterility compromise in breached pouches.
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 infection due to compromised sterility, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling 102 units of Reinforced Introducer Sets Maquet 7 Fr. (Part Number: 0684 00 0403 06). These accessories are used for the percutaneous insertion of MAQUET Intra Aortic Balloon Catheters. The recall is due to a potential for compromised sterility in breached pouches of specific lots.
The affected product was distributed in the United States and internationally to Switzerland, the Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bahrain, and Malaysia. The specific lot codes involved are 3000051658 and TLT.
Healthcare facilities and consumers should stop using the affected product immediately and contact Datascope Corporation for further instructions or a replacement.
The recalled product
- Product
- Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
- Manufacturer
- Datascope Corporation
- Affected units
- 102
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 (1)
- TLT
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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