Product code DSQ ยท Class 3
Ventricular (Assist) Bypass
0510(k)s in 12 months (0 all time)
8recalls in 12 months (131 all time)
1recalls that name a 510(k)
Top companies in DSQ
| Company | 510(k)s | Recalls |
|---|---|---|
| HeartWare Inc | 0 | 75 |
| Thoratec Corp | 0 | 42 |
| Abiomed, Inc. | 0 | 5 |
| Medtronic Inc | 0 | 3 |
| BERLIN HEART GMBH | 0 | 2 |
| Abbott | 0 | 1 |
| Datascope Corporation | 0 | 1 |
| Jarvik Heart Inc | 0 | 1 |
| Thoratec Switzerland GMBH | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Thoratec LLC Brand Name: HeartMate
Product Name: HM 11V Li-ion Backup Battery, ABT
Model/Catalog Number: 106128
Software Version: N/A
Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Batter Open, Classified |
DSQ | None listed |
| Jun 18, 2026 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate 3" System Controller
Model/Catalog Number: 106531US
Software Version: N/A
Product Description: The HeartMate 3" System Controller acts as the central powe Open, Classified |
DSQ | None listed |
| Jun 18, 2026 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits
Model/Catalog Number: 106524US
Software Version: N/A
Product Description: The HeartMate 3" Left Ventricular Assist S Open, Classified |
DSQ | None listed |
| Jun 5, 2026 | BERLIN HEART GMBH EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 Open, Classified |
DSQ | None listed |
| Nov 14, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate II Controller (standalone)
Model/Catalog Number: 106017, HeartMate II Pocket Controller, US; 106762, HeartMate II Pocket Controller, US; 107801, HeartMate Open, Classified |
DSQ | None listed |
| Nov 14, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate II LVAS Implant Kit
Model/Catalog Number: 106015, HeartMate II LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II LVAS Kit, with Pocket Co Open, Classified |
DSQ | None listed |
| Nov 14, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate 3 Controller (Standalone)
Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low F Open, Classified |
DSQ | None listed |
| Nov 14, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits
Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524
Software Vers Open, Classified |
DSQ | None listed |
| Aug 13, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: Mobile Power Unit
Model/Catalog Number: 107754
Software Version: N/A
Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipme Open, Classified |
DSQ | None listed |
| Aug 13, 2025 | Thoratec LLC Brand Name: HeartMate
Product Name: Mobile Power Unit, AC Power Cord
Model/Catalog Number: 107760
Software Version: N/A
Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a Open, Classified |
DSQ | None listed |
| Apr 17, 2025 | Thoratec LLC HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System. Open, Classified |
DSQ | None listed |
| Aug 13, 2024 | Thoratec LLC HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately:
HeartMate 3 LVAS Implant Kit, US, Model: 106524 Open, Classified |
DSQ | None listed |
| Jun 27, 2024 | Thoratec Switzerland GMBH 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System Open, Classified |
DSQ | None listed |
| Jun 7, 2024 | Thoratec Corp. Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device Open, Classified |
DSQ | None listed |
| May 1, 2024 | Thoratec Corp. Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly Open, Classified |
DSQ | None listed |
| May 1, 2024 | Thoratec Corp. Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly Open, Classified |
DSQ | None listed |
| Mar 22, 2024 | Thoratec Corp. HeartMate 3 Left Ventricular Assist System (LVAS):
1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE)
2. HeartMate 3 Sealed Outflow Graft with Bend Relief, Open, Classified |
DSQ | None listed |
| Mar 22, 2024 | Thoratec Corp. HeartMate II Left Ventricular Assist System (LVAS):
1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393
2. HeartMate II LVAS Implant Kit, US REF 106015
3. HeartMate II LVAS Implant Kit Open, Classified |
DSQ | None listed |
| Feb 2, 2024 | Thoratec Corp. 1. HeartMate Touch Communication System, REF HMT1100
2. HeartMate Touch Communication System, Rental REF HMT1100-R
3. HeartMate Touch Communication System, HMT1150
The HeartMate Touch Application is Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 Open, Classified |
DSQ | None listed |
| Dec 2, 2023 | Heartware, Inc. HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 Open, Classified |
DSQ | None listed |
| Sep 29, 2023 | Thoratec Corp. Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050 Open, Classified |
DSQ | None listed |
| Jun 22, 2023 | Heartware, Inc. HeartWare Ventricular Assist Device System.
a) Monitor 1521US Explore Tech,
b) Monitor 1521GB Explore Tech,
c) Monitor 1521IL Explore Tech,
d) Monitor 1521DE Explore Tech Open, Classified |
DSQ | None listed |
| May 25, 2023 | BERLIN HEART GMBH EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 Terminated |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare HVAD Pump Kit, REF MCS1705PU Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare HVAD Pump Kit, REF 1205 Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare HVAD Pump Kit, REF 1104JP Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare HVAD Pump Kit, REF 1104CA-CLIN Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare HVAD Pump Kit, REF 1104 Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare HVAD Pump Kit, REF 1103 Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare Model 1102 Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare Model 1101 Open, Classified |
DSQ | None listed |
| Dec 21, 2022 | Heartware, Inc. HeartWare Model 1100 Open, Classified |
DSQ | None listed |
| Oct 24, 2022 | Datascope Corporation LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter. Open, Classified |
DSQ | K041281 |
| Aug 18, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE Open, Classified |
DSQ | None listed |
| May 5, 2022 | Medtronic Inc HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System. Open, Classified |
DSQ | None listed |
| Apr 14, 2022 | Medtronic Inc HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU Open, Classified |
DSQ | None listed |
| Mar 30, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets:
HVAD System Emergency Responder Guide (FI-Finnish)
HVAD System Emergency Responder Guide (FI-Finnish)
HVAD System Emergency Re Open, Classified |
DSQ | None listed |
| Mar 30, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH Open, Classified |
DSQ | None listed |
| Mar 30, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0 Open, Classified |
DSQ | None listed |
| Mar 30, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 Open, Classified |
DSQ | None listed |
| Mar 30, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit Open, Classified |
DSQ | None listed |
| Mar 30, 2022 | Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 Open, Classified |
DSQ | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.