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System, Balloon, Intra-Aortic And Control

FDA product code DSP · Class 2 · Cardiovascular

521
Registered devices
67,887
Adverse events
194
Recalls
162
510(k) clearances

Devices with this code

Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB — DATASCOPE CORP.ARROW — TELEFLEX INCORPORATEDCS300 Accessory Kit, Japanese 110 V — Datascope Corp.Linear 7.5Fr. 25cc IAB (with APA) US Only — DATASCOPE CORP.CARDIOSAVE HYBRID TYPE M PLUG — Datascope Corp.CS100 Intra-Aortic Balloon Pump, German, 220V — Datascope Corp.ARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDCS100 UTS Intra-Aortic Balloon Pump SPANISH 110V — Datascope Corp.ARROW — TELEFLEX INCORPORATEDCARDIOSAVE BATTERY CHARGING STATION — Datascope Corp.Ultra IABP Catheter Kit — INSIGHTRA MEDICAL, INC.CABLE,ECG TRUNK,5L,3.3K,AAMI — Datascope Corp.CS100 UTS Intra-Aortic Balloon Pump ENG DOMSTC — Datascope Corp.MEGA 7.5 Fr. 40cc IAB W/O Statlock (APA) - INDIA — DATASCOPE CORP.ARROW — TELEFLEX INCORPORATEDCS300 Intra-Aortic Balloon Pump, Refurbished, SPANISH,UTS,INTL — Datascope Corp.ARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDCABLE,LOW LEV OUTPUT,DATASCOPE — Datascope Corp.ARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATED

Recent recalls

DateFirmReason
2026-02-06Datascope Corp.The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate t
2026-01-23Datascope Corp.The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
2026-01-23Datascope Corp.The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
2025-11-04Datascope Corp.The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
2025-11-04Datascope Corp.The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
2025-10-23Datascope Corp.The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
2025-10-23Datascope Corp.The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
2025-07-19Insightra Medical IncDevice contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions
2024-09-17Datascope Corp.There is discrepant labeling on the inner and outer packaging of the device.
2024-08-08Datascope Corp.Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.