Possis Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 35
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Possis Medical, Inc. makes
Possis Medical, Inc. manufactures devices for vascular interventions, including rheolytic thrombectomy catheters like the AngioJet X-Stream, AngioJet Ultra XSpeedior, and AngioJet XSpeedior 120 for clot removal, as well as aspiration catheters such as the Fetch for debris extraction. The company also produces vascular grafts, including the Perma-Pass 6S and 6T grafts, and coronary cannulas for procedural support. Electrophysiology leads, such as the Myopore Unipolar models 1117 and 1118, are part of the portfolio, alongside modifications to the GuardDog occlusion system for vascular access.
The company’s devices are regulated under FDA pathways, with Class II and Class III classifications requiring 510(k) clearances or Premarket Approval (PMA) submissions. Products are listed in the FDA’s 510(k) and PMA registries, reflecting their authorised status for use in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 35 devicesFDA recalls
FDA recall records list 4 recalls initiated by Possis Medical, Inc., the earliest on 2005-12-12 and the most recent on 2007-06-19. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 19 Jun 2007 Z-1131-2007 Unclassified (pre-2012) Terminated Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries.
- 1 May 2007 Z-0954-2007 Unclassified (pre-2012) Terminated Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
Full distribution text
- 1 May 2007 Z-0955-2007 Unclassified (pre-2012) Terminated Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
Full distribution text
2005
- 12 Dec 2005 Z-0469-06 Unclassified (pre-2012) Terminated It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.
Frequently asked questions
How many devices does Possis Medical, Inc. have in the registry?
The registry currently lists 35 devices for Possis Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Possis Medical, Inc.'s devices?
Among its 35 most recently registered devices, Possis Medical, Inc. has devices listed in FDA 510(k) (34 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Possis Medical, Inc.'s devices fall under?
Among its 35 most recently registered devices, the classes recorded for Possis Medical, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Possis Medical, Inc.?
FDA recall records list 4 recalls initiated by Possis Medical, Inc., the most recent initiated on 2007-06-19. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Possis Medical, Inc. in the registry?
The most recently registered devices listed for Possis Medical, Inc. include MODIFICATION TO GUARDDOG OCCLUSION SYSTEM, FETCH ASPIRATION CATHETER, POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 and ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039.