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Recall Observatory FDA recall evidence

Device product

Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.

Z-1967-2012

June 06, 2012

Class II

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 52194
Status
Terminated
Classification
Class II
Quantity
1524 units
Official record key
device-enforcement:Z-1967-2012

Official wording

Reason: Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.

Code information: Lot numbers: 58749813, 58802303, 58836847, 58877405, 58909346, 59011910, 59035360, 59085935, 59118391, 59241531, 58705682, 58711964, 58722234, 58771175, 58837337, 58855247, 58904182, 58927518, 58936037, 58936014, 58936027, 59009635, 59030253, 59056470, 59103213, 59124020, 59199172, 59218725, 59235997.

Distribution pattern: Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.

Field note

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