CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report

Rigid Suction Wand, sterile recalled by Edwards Lifesciences

Edwards Lifesciences is recalling Rigid Suction Wand, sterile, distributed nationwide in the US. The recall was initiated on 6 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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.

Quantity recalled1524 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1967-2012
FDA event ID: 52194
Recalling firm: Edwards Lifesciences, Draper, UT
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2012
FDA classified: 9 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

6 Jun 2012	Recall initiated by company
9 Jul 2012	Classified by FDA	+33 days
18 Jul 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arizona California Connecticut Maryland Missouri Texas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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