The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2053-2017·Announced 2017-05-31

St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers 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 intended to make the exchange to a backup controller easier.

This recall is related to recall Z-1227/1230-2014. The affected product is the HeartMate II LVAS with Pocket Controller, manufactured by Thoratec Corporation, which is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure.

The source text does not specify the number of affected units, specific serial numbers, or distribution locations for this specific recall action. Users should contact St. Jude Medical or their healthcare provider for instructions on obtaining the software and hardware updates.

The recalled product

Product
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; 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
Hazard
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 (20)

  • Serial Numbers PC-10255-B
  • PC-10329-B
  • PC-10357-B
  • PC-10476-B
  • PC-10478-B
  • PC-10486-B
  • PC-10518-B
  • PC-10519-B
  • PC-10524-B
  • PC-10525-B
  • PC-10538-B
  • PC-10540-B
  • PC-10544-B
  • PC-10626-B
  • PC-10629-B
  • PC-10973-C
  • PC-10976-C
  • PC-10977-C
  • PC-10986-C
  • PC-10988-C

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 →

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