Edwards Lifesciences Recalls Rigid Suction Wands Due to Tip Detachment Risk
Edwards Lifesciences is recalling Rigid Suction Wands (models S033 and SPC2081) because the plastic tip may detach during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for harm (tip detachment) during a surgical procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling 1,524 units of Rigid Suction Wands, models S033 and SPC2081. These sterile medical devices are used to remove fluid from the external surface of the heart during cardiac surgery.
The recall was initiated because the plastic tip attached to the metal suction wand may become detached during routine use. The affected units were distributed worldwide, including nationwide in the United States and in Europe and Japan.
Healthcare facilities and users should stop using the affected devices and contact Edwards Lifesciences for further instructions. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- 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…
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 1,524
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)
- Lot numbers: 58749813
- 58802303
- 58836847
- 58877405
- 58909346
- 59011910
- 59035360
- 59085935
- 59118391
- 59241531
- 58705682
- 58711964
- 58722234
- 58771175
- 58837337
- 58855247
- 58904182
- 58927518
- 58936037
- 58936014
Distribution
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