Recall Z-0099-2019 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
| Date | Oct 27, 2018 (initiated Sep 20, 2018) |
| Status | Open, Classified |
| Reason | There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft. |
| Root cause | Device Design |
| Action | On September 20, 2018, Maquet/Getinge issued a press release. On September 24, 2018 and on September 28, 2018, Maquet/Getinge issued URGENT MEDICAL DEVICE CORRECTION notices along with an Instructions for Use Addendum to customers. On October 23, 2018 a modified version of the Urgent Medical Device Correction Letter and response form was sent to 23 new U.S. consignees who received Cardiosave IABP devices after the ship-hold was released. The post ship-hold devices contain the IFU addendum. This modified version of the letter notifies customers of the altitude issue and the required software |
| Distribution | US Nationwide; Internationally to 77 countries |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp., May 31, 2018 |