Devices

Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore

Model / Serial
Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. || Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.
Manufacturer
AngioScore Inc.
1 Event
- Recall of Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore

Manufacturer

AngioScore Inc.

Manufacturer Address
AngioScore Inc., 5055 Brandin Ct, Fremont CA 94538-3140
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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