Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
This recall is currently active, issued October 27, 2018. It was issued by Maquet Datascope Corp Cardiac Assist Division.
- Recall Initiated
- September 20, 2018
- Posted
- October 27, 2018
- Recall Number
- Z-0100-2019
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide; Internationally to 77 countries
Lot / Code Info
UDI - 10607567108407 All Serial Numbers
Root Cause
Device Design
Action Taken
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 update. Maquet/Getinge is currently developing a software correction to address this issue. Customers are encouraged to use the following items as specified according to altitude levels: Sensation 34cc / 40cc (Balloon Name and Size) Sensation Plus 40cc / 50cc (Balloon Name and Size) Operating Altitude: -1250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1060 hPa to 901 hPa) Mega 50cc (Balloon Name & Size) Operating Altitude: -1250 feet to 5000 feet (795 mmHg to 632 mmHg) (1060 hPa to 843 hPa) Mega 30cc / 40cc (Balloon Name & Size) Linear 25cc / 34cc / 40cc (Balloon Name & Size) Operating Altitude: -1250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1060 hPa to 644 hPa) For technical questions, please contact Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST