Z-1469-2021 Class II Ongoing
FDA device recall Z-1469-2021 was initiated by Heartware, Inc. on February 26, 2021 and is designated Class II. Reason for recall: IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean th… The recall status is ongoing. Affected quantity: 23123 (11292 US).
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23123 (11292 US)
Product Description
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.
Reason for Recall
IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604
Distribution Pattern
Worldwide distribution, including: US nationwide, Italy, Great Britain, Germany, Japan
Code Information
All serial numbers as of February 26, 2021. Model, GTIN: 1100, No GTIN Available; 1101, No GTIN Available; 1102, No GTIN Available; 1103, 00888707000017; 1104, No GTIN Available; 1104JP, 00888707000697; 1205, No GTIN Available; MCS1705PU, 00888707005364; 1403US, 00888707000475; 1407AU, 00888707001663; 1407CA, 00888707002851; 1407CH, 00888707001694; 1407DE, 00888707001700; 1407GB, 00888707001717; 1407IL, 00888707001724; 1407IN, 00888707001731; 1407IT, 00888707001748; 1407JP, 00888707001755; 1407KR, 00888707001762; 1420, 00888707000420; 1420JP, 00888707000437; 1430AR, 00888707000826; 1430AU, 00888707000833; 1430CA, 00888707000857; 1430CH, 00888707000871; 1430DE, 00888707000864; 1430GB, 00888707000888; 1430IL, 00888707000901; 1430IN, 00888707000505; 1430IT, 00888707000895; 1430JP, 00888707000918; 1430US, 00888707000307; 1440, 00888707001885; 1575, 00888707008051; 1650, 00888707000376; 1650CA-CLIN, 00888707001588; 1650DE, 00888707001373; 1475, 00888707008037; 2050, 00888707008082; 2050IL, 00888707001410; 2050US, 00888707000048; 2060, 00888707008099; 2060IL, 00888707001427; 2060US, 00888707000055;