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AngioSculpt Percutaneous Transluminal Coronary Angioplasty… recallZ-2218-2010 · AngioScore Inc. · initiated Dec 4, 2009

Terminated All recalls posted in August 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from AngioScore Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.

FDA root cause category: Process design

What the company is doing

AngioScore sent an "Urgent: Medical Device Voluntary Recall" dated December 4, 2009 addressed to "Catheterization Lab Manager" at consignees. The Recall notification letter instructed consignees to inspect their inventory to detect product from the involved lot, and segregate it from their inventory. Consignees were asked to record all affected product and fax return forms to the firm. AngioScore Customer Service will contact consignees and provide instructions for return and replacement of affected product.. Consignees can contact AngioScore at 877-264-4692.

Recall details

Recall number
Z-2218-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 4, 2009
Posted by the FDA
Aug 18, 2010
Recalling firm
AngioScore Inc.
Quantity
3870 units
Product code
NWX
FDA submissions
P050018
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.

Code information (models, lots, serial numbers)

Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003

Other devices under the same FDA submission

21 devices cleared under P050018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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