Boston Scientific, Target
Country not established
- Devices
- 19
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Boston Scientific, Target makes
The company manufactures embolization coils, including detachable variants such as the Matrix, GDC Stretch Resistant, and In-Time Retrieval devices, designed for vascular occlusion procedures. It also produces Guglielmi Detachable Coil (GDC) variants, including soft and 3D-shaped models, along with associated power supplies and cables. Additionally, the portfolio includes coronary imaging catheters like the Atlantis SR Plus and Atlantis PV for intravascular imaging.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company operates under US jurisdiction, with its products listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 19 devicesFDA recalls
FDA recall records list 8 recalls initiated by Boston Scientific, Target, the earliest on 2006-03-06 and the most recent on 2007-07-11. By recorded status: 8 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 11 Jul 2007 Z-0259-2008 Unclassified (pre-2012) Terminated Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)
- 11 Jul 2007 Z-0260-2008 Unclassified (pre-2012) Terminated Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)
- 14 Jun 2007 Z-0122-2008 Unclassified (pre-2012) Terminated Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
- 7 Feb 2007 Z-0668-2007 Unclassified (pre-2012) Terminated The product may be missing the temperature indicator label on the inner pouch.
Full distribution text
2006
- 1 Dec 2006 Z-0395-2007 Unclassified (pre-2012) Terminated The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.
- 13 Oct 2006 Z-0177-2007 Unclassified (pre-2012) Terminated Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)
- 26 Apr 2006 Z-0895-06 Unclassified (pre-2012) Terminated During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
Full distribution text
- 6 Mar 2006 Z-0789-06 Unclassified (pre-2012) Terminated Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only)
Frequently asked questions
How many devices does Boston Scientific, Target have in the registry?
The registry currently lists 19 devices for Boston Scientific, Target. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boston Scientific, Target's devices?
Among its 19 most recently registered devices, Boston Scientific, Target has devices listed in FDA 510(k) (19 devices).
What risk classes do Boston Scientific, Target's devices fall under?
Among its 19 most recently registered devices, the classes recorded for Boston Scientific, Target's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Boston Scientific, Target?
FDA recall records list 8 recalls initiated by Boston Scientific, Target, the most recent initiated on 2007-07-11. 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 Boston Scientific, Target in the registry?
The most recently registered devices listed for Boston Scientific, Target include MATRIX DETACHABLE COILS, GDC STRETCH RESISTANT DETACHABLE COIL, IN-TIME RETRIEVAL DEVICE and GUGLIELMI DETACHABLE COIL (GDC).