Datascope Recalls Intra-Aortic Balloon Catheters Due to Incorrect Instruction Manual
Datascope is recalling Mega and Sensation Plus Intra-Aortic Balloon Catheter kits because they were packaged with the wrong instruction manual for the STATLOCK device.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is typically associated with minor labeling errors or low-risk contamination. The source text describes a packaging error involving the wrong instruction manual, which fits the criteria for a moderate severity recall without reported injuries.
Plain-English summary
Datascope Corporation is recalling specific lots of MEGA and Sensation Plus Intra-Aortic Balloon Catheter kits. The recall involves 31,030 units in the United States and 15,604 units outside the United States, distributed worldwide.
The recall was initiated after it was discovered during post-quarantine packaging on February 16, 2016, that the kits were erroneously packaged with the instruction manual (IFU) for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer. The kits should have contained the IFU for the STATLOCK Catheter Stabilization device for IAB catheters.
Healthcare facilities and distributors should stop using the affected kits and contact Datascope Corporation for instructions on how to return the products. The affected product codes are PN 0684-00-0294-01U, PN 0684-00-0294-02U, PN 0684-00-0295-01U, PN 0684-00-0295-02U, and PN 0684-00-0296-01U.
The recalled product
- Product
- MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic…
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Catheters
- Hazard
Distribution
Distribution scope not specified by the agency.
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