Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-0...
FDA Device Recall #Z-2833-2020 — Class II — July 27, 2020
Recall Summary
| Recall Number | Z-2833-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 27, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Datascope Corporation |
| Location | Fairfield, NJ |
| Product Type | Devices |
| Quantity | 31529 WW |
Product Description
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Reason for Recall
Potential Endotoxin Contamination
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
Lot / Code Information
Kit Lot Number: 3000046414 3000047431 3000048243 3000049080 3000049569 3000050495 3000051154 3000051751 3000053311 3000054591 3000054592 3000056356 3000056629 3000058277 3000060542 3000064249 3000066800 3000065563 3000067963 3000070668 3000071291 3000071979 3000073516 3000074146 3000075999 3000078921 3000080138 3000080137 3000081624 3000082197 3000082848 3000083430 3000084785 3000086995 3000087888 3000089898 3000091753 3000092239 3000092240 3000094450 3000094451 3000095604 3000096970 3000097957 3000100722 3000105063 3000102628 3000105064 3000107101 3000108962 3000109818 3000112782 3000046415 3000047430 3000048245 3000049085 3000049570 3000051153 3000051881 3000053310 3000054729 3000056538 3000059168 3000059618 3000060730 3000060451 3000064248 3000066798 3000065636 3000066799 3000067964 3000070669 3000071292 3000071980 3000073517 3000074144 3000074145 3000076000 3000078922 3000080140 3000082847 3000083431 3000083989 3000084730 3000087112 3000088376 3000089899 3000091754 3000092134 3000094449 3000095692 3000096971 3000097952 3000097953 3000100721 3000102697 3000105062 3000107100 3000109817 3000111681 3000113153 3000048244 3000049567 3000050496 3000051155 3000053312 3000054730 3000059169 3000060545 3000060543 3000066063 3000064842 3000064843 3000066801 3000066802 3000066803 3000076001 3000080543 3000080544 3000081621 3000082189 3000084786 3000086996 3000091755 3000092238 3000097956 3000102698 3000105060 3000106965 3000112155 3000112156 3000046416 3000047435 3000049568 3000056539 3000059619 3000064250 3000066804 3000066805 3000067857 3000070670 3000073518 3000074162 3000078923 3000080139 3000084731 3000097954 3000102699 3000108432 3000112154 3000103022 3000047356 3000048230 3000049055 3000051378 3000054590 3000056355 3000056628 3000059148 3000060544 3000068926 3000068941 3000073404 3000074166 3000074890 3000076131 3000076402 3000078920 3000080420 3000081777 3000083598 3000085937 3000090852 3000089347 3000091872 3000094108 3000094935 3000096067 3000095318 3000096066 3000097959 3000100857 3000100582 3000102905 3000105061 3000107102 3000108963 3000111680 3000113152 3000068029 3000071836 3000074163 3000103039 3000106964
Other Recalls from Datascope Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0131-2023 | Class II | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), ... | Aug 5, 2022 |
| Z-1687-2022 | Class II | Insertion Kit for use with SENSATION PLUS 8F. 5... | Aug 5, 2022 |
| Z-1686-2022 | Class II | Sensation Plus 8Fr 50cc Intra-Aortic Balloon Ca... | Aug 5, 2022 |
| Z-1685-2022 | Class II | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter | Aug 5, 2022 |
| Z-2839-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-... | Jul 27, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.