VenaSeal, Sapheon Closure System, Model # SP-101, VS-301… recallZ-1599-2015 · Covidien LLC · initiated Apr 28, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
FDA root cause category: Package design/selection
What the company is doing
Consignees were contacted by letter via email on April 28, 2015.
Recall details
- Recall number
- Z-1599-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 28, 2015
- Posted by the FDA
- May 12, 2015
- Recalling firm
- Covidien LLC
- Quantity
- 1661 units
- Product code
- PJQ
- FDA submissions
- P140018
- Distribution
- Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
Product description
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under P140018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VenaSeal™ VS-402Medtronic, Inc. · Agent, occluding, vascular, permanent1 recall2 deaths65 reports
- VenaSeal VS-402Covidien LP · Agent, Occluding, Vascular, Permanent7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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