• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Absorb Bioresorbable Vascular Scaffold (BVS) System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall Absorb Bioresorbable Vascular Scaffold (BVS) System see related information
Date Initiated by Firm April 26, 2017
Date Posted June 01, 2017
Recall Status1 Open3, Classified
Recall Number Z-2151-2017
Recall Event ID 77131
PMA Number P150023 
Product Classification Absorbable coronary drug-eluting stent - Product Code PNY
Product Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia).
The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.


Code Information Australia:, Part No. Description, 1012462-08 2.5 x 08 mm Absorb BVS, 1012462-12 2.5 x 12 mm Absorb BVS, 1012462-18 2.5 x 18 mm Absorb BVS, 1012462-23 2.5 x 23 mm Absorb BVS, 1012462-28 2.5 x 28 mm Absorb BVS, 1012463-08 3.0 x 08 mm Absorb BVS, 1012463-12 3.0 x 12 mm Absorb BVS, 1012463-18 3.0 x 18 mm Absorb BVS, 1012463-23 3.0 x 23 mm Absorb BVS, 1012463-28 3.0 x 28 mm Absorb BVS, 1012464-12 3.5 x 12 mm Absorb BVS, 1012464-18 3.5 x 18 mm Absorb BVS, 1012464-23 3.5 x 23 mm Absorb BVS, 1012464-28 3.5 x 28 mm Absorb BVS

Recalling Firm/
Manufacturer
Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer Reason
for Recall
Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent.
FDA Determined
Cause 2
Other
Action Abbott Vascular sent an Urgent Medical Device Recall and Hazard Alert letter dated April 26, 2017, to affected customers to inform them that the action is in response to recent concerns over data from some studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent. Customers were informed of the actions to be taken. Customers were instructed to stop using these devices immediately, advise BVS patients to follow the recommendations for DAPT prescribed by their health care provider. Advise patients experiencing new cardiac symptoms to seek clinical care, review their inventory and complete the attached Facsimile Reply Form and display and share this notification with other relevant personnel within their organization. Customers with questions are instructed to contact their local Abbott Vascular Representative or Customer Service department.
Quantity in Commerce 590 units
Distribution Australia
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = PNY and Original Applicant = ABBOTT VASCULAR INC.
-
-