Possis Medical, Inc Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).
Brand
Possis Medical, Inc
Lot Codes / Batch Numbers
Model # 104504-001 Lot Nos: 72285 and 72794
Products Sold
Model # 104504-001 Lot Nos: 72285 and 72794
Possis Medical, Inc is recalling Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxi due to Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
Recommended Action
Per FDA guidance
Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026