Datascope Corp.
FDA Regulatory Profile
Datascope Corp. appears in FDA public data with 67 recalls — including 31 Class I (most serious) —, 136 510(k) clearances, 8 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-1587-2026, Class III) was initiated on February 6, 2026. Its most recent 510(k) clearance was granted on December 26, 2019.
Summary
- Total Recalls
- 67 (31 Class I)
- 510(k) Clearances
- 136
- Inspections
- 8
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1587-2026 | Class III | Battery Charging Station; Model: 0998-00-0802; | February 6, 2026 |
| Z-1486-2026 | Class II | CS100 IABP. Software Version CS100 IABP Q.01. | January 23, 2026 |
| Z-1487-2026 | Class II | CS300 IABP. Software Version CS300 IABP C.01. | January 23, 2026 |
| Z-0916-2026 | Class II | Cardiosave Hybrid. Intra-Aortic Balloon Pump system. | November 4, 2025 |
| Z-0917-2026 | Class II | Cardiosave Rescue. Intra-Aortic Balloon Pump system. | November 4, 2025 |
| Z-0931-2026 | Class III | Cardiosave Hybrid | October 23, 2025 |
| Z-0932-2026 | Class III | Cardiosave Rescue | October 23, 2025 |
| Z-0311-2025 | Class II | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 | September 17, 2024 |
| Z-3136-2024 | Class I | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def | August 8, 2024 |
| Z-3135-2024 | Class I | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def | August 8, 2024 |
| Z-3134-2024 | Class I | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def | August 8, 2024 |
| Z-3137-2024 | Class I | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def | August 8, 2024 |
| Z-2436-2023 | Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, | July 31, 2023 |
| Z-2487-2023 | Class II | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, | July 31, 2023 |
| Z-2431-2023 | Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, | July 31, 2023 |
| Z-2437-2023 | Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, | July 31, 2023 |
| Z-2486-2023 | Class II | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, | July 31, 2023 |
| Z-2432-2023 | Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, | July 31, 2023 |
| Z-2438-2023 | Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, | July 31, 2023 |
| Z-2435-2023 | Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, | July 31, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | December 26, 2019 |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | May 31, 2018 |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | October 12, 2017 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Stor | January 31, 2017 |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | July 2, 2015 |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | December 12, 2013 |
| K071805 | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX | September 25, 2007 |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | February 14, 2007 |
| K062098 | SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX | February 5, 2007 |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON P | January 5, 2007 |
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 | November 2, 2006 |
| K051897 | TRIO MONITOR | August 12, 2005 |
| K042016 | DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER | September 23, 2004 |
| K041907 | TRIO MONITOR | July 23, 2004 |
| K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES | June 7, 2004 |
| K032338 | TRIO MONITOR MODEL 0998-00-0600 | February 11, 2004 |
| K031760 | VIEWPOINT TELEMETRY SYSTEM | October 10, 2003 |
| K031849 | SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX | September 9, 2003 |
| K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX | August 11, 2003 |
| K031569 | DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX | June 10, 2003 |