Trivascular Recalls Fill Polymer Kits Due to Potential Stopcock Leaks
Trivascular is recalling 41 units of Fill Polymer Kits in European distributor inventory due to potential stopcock cracks that may cause leaks.
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 defect that could compromise the integrity of the device during use, posing a risk of harm, but no injuries or illnesses have been reported.
Plain-English summary
Trivascular, Inc. is recalling 41 units of the TriVascular brand Fill Polymer Kit, European Model Number TVFP14-B. The recall is limited to units currently in European distributor inventory. The affected kits are intended for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems.
The recall was initiated because the stopcock component in these kits may have cracks, which could result in leaking upon the initiation of the mix process, prior to use in a patient. TriVascular stated that no purchased devices are currently in hospital inventory in Europe or the U.S.
The affected lots are FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01, and FF051012-01. The distribution pattern includes the United States and the countries of Belgium, Cyprus, Italy, Spain, Switzerland, and Turkey. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact Trivascular for further instructions.
The recalled product
- Product
- TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an…
- Manufacturer
- Trivascular, Inc
- Hazard
- Affected units
- 41
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 (8)
- The following lot numbers are in distributor inventory in Europe: FF121211-04
- FF010912-01
- FF013112-01
- FF020912-01
- FF022212-03
- FF022912-01
- FF040412-01
- FF051012-01
Distribution
Distributed nationwide across the United States.
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