St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall
St. Jude Medical is updating software and hardware for HeartMate II LVAS devices to facilitate the exchange to a backup controller.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014."
Plain-English summary
St. Jude Medical is providing all users of the HeartMate II LVAS with Pocket Controller with new software and updates to hardware. This action is taken to make the exchange to a backup controller easier. The recall is related to recall Z-1227/1230-2014.
The affected product is the HeartMate II LVAS with Pocket Controller, manufactured by Thoratec Corporation. The device is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure and is intended for use inside or outside the hospital. There are 24,077 active units in the US.
The distribution pattern includes worldwide distribution across the US and numerous international locations including Austria, Belgium, Brazil, Canada, and others. All serial numbers are affected. Users should contact St. Jude Medical or their healthcare provider for instructions on receiving the new software and hardware updates.
The recalled product
- Product
- HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
- Manufacturer
- Thoratec Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 24,077
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial numbers.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Thoratec Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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See all →- SevereSt. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
FDA (Devices) · 2017-05-31
- SevereSt. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
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- CriticalThoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths
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