Edwards Lifesciences, LLC: Medical Device Recall in 2012 - (Recall #: Z-1967-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 6, 2012

Date Posted: July 18, 2012

Recall Number: Z-1967-2012

Event ID: 52194

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.

Status: Terminated

Product Quantity: 1524 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated