Data / Medical devices / United States / Datascope Corp.
Datascope Corp.: FDA-registered device maker in Fairfield, NJ, United States, 7 510(k) clearances
Datascope Corp. is registered with the FDA (registration 2248146) in Fairfield, NJ, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 12, 2013. 21 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2248146
- FEI number
- 1000222374
- Address
- 15 Law Dr, Fairfield, NJ, United States, 07004
- Owner or operator
- Datascope Corp. (2221819)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 25, 2003
- Registered through
- 2026
- Brand names listed
- CS300 Intra-Aortic Balloon Pump, LINEAR 7.5Fr. IAB Catheter & Accessories, MEGA 7.5FR. 30cc Intra-Aortic Balloon Catheter & Accessories, MEGA 8Fr. 50cc IAB Catheter & Accessories, SENSATION 7Fr. IAB Catheter & Accessories, SENSATION PLUS 7.5Fr. 40cc IAB Catheter & Accessories, SENSATION PLUS 8Fr. 50cc IAB Catheter & Accessories, STATLOCK IAB Stabilization Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Intravascular Catheter Securement | KMK | 1 | Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Balloon, Intra-Aortic And Control | DSP | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2013 | K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| September 6, 2012 | K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES | DSP | Substantially Equivalent | Datascope Corp., Cardiac Assist Division | accessdata.fda.gov |
| April 20, 2012 | K120868 | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER | DSP | Substantially Equivalent | Datascope Corp., Cardiac Assist Division | accessdata.fda.gov |
| January 5, 2007 | K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| June 7, 2004 | K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES | DSP | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| August 25, 2000 | K002365 | DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET | DYB | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| December 22, 1995 | K943896 | GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS | DQX | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 17, 2024 | 95396 | Class II | Ongoing | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 | There is discrepant labeling on the inner and outer packaging of the device. | accessdata.fda.gov |
| June 23, 2023 | 92527 | Class II | Ongoing | YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-05 | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious advers | accessdata.fda.gov |
| August 5, 2022 | 90913 | Class II | Ongoing | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter. | The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable. | accessdata.fda.gov |
| August 5, 2022 | 90684 | Class II | Ongoing | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter | Certain lots containing undersized dilator. | accessdata.fda.gov |
| July 27, 2020 | 85823 | Class II | Ongoing | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Ca | Potential Endotoxin Contamination | accessdata.fda.gov |
| November 20, 2019 | 84521 | Class II | Terminated | Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters. | Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs. | accessdata.fda.gov |
| May 28, 2019 | 83022 | Class II | Terminated | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that include | The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured. | accessdata.fda.gov |
| February 21, 2018 | 79646 | Class II | Terminated | Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and def | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section. | accessdata.fda.gov |
| October 19, 2017 | 79873 | Class II | Terminated | BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. | accessdata.fda.gov |
| July 27, 2017 | 80081 | Class II | Terminated | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. | accessdata.fda.gov |
| April 12, 2017 | 76942 | Class II | Terminated | SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary p | Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified. | accessdata.fda.gov |
| February 16, 2017 | 76518 | Class II | Terminated | Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tub | A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port. | accessdata.fda.gov |
| May 13, 2016 | 74225 | Class II | Terminated | 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 & | It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 240309 | accessdata.fda.gov |
| May 9, 2016 | 74341 | Class II | Terminated | Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile | Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits. | accessdata.fda.gov |
| March 11, 2016 | 80086 | Class III | Terminated | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588 | There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE. | accessdata.fda.gov |
| August 11, 2014 | 69072 | Class III | Terminated | LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group | During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter. | accessdata.fda.gov |
| May 10, 2010 | 55649 | Not yet classified | Terminated | CS100 Intra-Aortic Balloon Pump. | Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen. | accessdata.fda.gov |
| February 4, 2009 | 51178 | Not yet classified | Terminated | Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor. | Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor. | accessdata.fda.gov |
| October 9, 2007 | 45405 | Not yet classified | Terminated | Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ | Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen, and subsquent arrthymia ala | accessdata.fda.gov |
| May 7, 2007 | 38005 | Not yet classified | Terminated | Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope | Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device. | accessdata.fda.gov |
| March 21, 2003 | 25995 | Not yet classified | Terminated | 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction wit | 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Guide, Catheter
- All makers of Device, Intravascular Catheter Securement
- All makers of System, Balloon, Intra-Aortic And Control
- All makers of Introducer, Catheter
Updated November 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.