Z-1599-2015Class II

VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use

Name: Z-1599-2015 VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use
Creator: Covidien LLC
Published: 2015-04-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-04-28 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use on 2015-04-28. FDA classified it as Class II and gives the reason as "Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1599-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-28
Posted: 2015-05-12
Terminated: 2016-03-29
Recalling firm: Medtronic, Inc.
Product: VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Product code: PJQ Agent, Occluding, Vascular, Permanent
Reason for recall: Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees were contacted by letter via email on April 28, 2015.
Quantity in commerce: 1661 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1599-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1599-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-12

Product code PJQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)