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 risk-of-harm product (compromised sterility in a medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Datascope Corporation is recalling 523 units of Reinforced Introducer Sets (Maquet 8 Fr., Part Number: 068400040310). These medical accessories are used for the percutaneous insertion of MAQUET IntraAortic 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 several international countries, including Switzerland, the Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bahrain, and Malaysia. Specific lot codes involved in this recall include 3000079612, 3000043101, 3000036631, 3000015016, and TTP.
Healthcare providers and facilities should check their inventory for the specific part number and lot codes listed above. If the product is found, it should be removed from use and returned to the manufacturer or their authorized representative according to the recall instructions.
The recalled product
- Product
- Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
- Manufacturer
- Datascope Corporation
- Hazard
- Affected units
- 523
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 (4)
- 3000043101
- 3000036631
- 3000015016
- TTP.
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
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
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Similar recalls
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FDA (Devices) · 2023-08-02
- HighDatascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
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- ModerateDatascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels
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- ModerateDatascope Recalls Intra-Aortic Balloon Catheters Due to Incorrect Instruction Manual
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- HighUndersized Dilator in Balloon Catheter Insertion Kit Recalled
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- LowDatascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error
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