CLASS II Device recall · Reported 20 May 2015 · FDA Enforcement Report
VenaSeal, Sapheon Closure System recalled by Covidien
Covidien is recalling VenaSeal, Sapheon Closure System. The recall was initiated on 28 Apr 2015 and the FDA has classified it as Class II.
Check your package
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-1599-2015
- FDA event ID
- 71138
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Apr 2015
- FDA classified
- 12 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 28 Apr 2015 | Recall initiated by company | |
| 12 May 2015 | Classified by FDA | +14 days |
| 20 May 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Where it was distributed
Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
Questions about this recall
Is VenaSeal, Sapheon Closure System recalled?
Yes. Covidien recalled VenaSeal, Sapheon Closure System on 28 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1599-2015.
Why was it recalled?
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Which lots are affected?
Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075.; Model no. VS-301, Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160; Model no. VS-402, Lots 39970, 39971, 39972, 39973, 40067, 40069, 40187, 40243, 40271 and 40272.
Where was it sold?
Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
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 21 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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