Edwards Lifesciences Rigid Suction Wand — Class II medical device recall Z-1967-2012
Terminated recall by Edwards Lifesciences, LLC, reported 2012-07-18, distributed nationwide. Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suctio
| Recall number | Z-1967-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2012-06-06 |
| Classified | 2012-07-09 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2012-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 1,524 units |
| Reason classes | device malfunction |
| Lot numbers | 58705682, 58711964, 58722234, 58749813, 58771175, 58802303, 58836847, 58837337, 58855247, 58877405, 58904182, 58909346, 58927518, 58936014, 58936027, 58936037, 59009635, 59011910, 59030253, 59035360, 59056470, 59085935, 59103213, 59118391, 59124020, 59199172, 59218725, 59235997, 59241531 |
| Model numbers | S033, SPC2081 |
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.