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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Scimed

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 Class 2 Device Recall Boston Scientific Scimedsee related information
Date Initiated by FirmAugust 20, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on October 24, 2005
Recall NumberZ-0032-04
Recall Event ID 27231
PMA NumberP860019 
Product Classification Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
ProductAce Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Code Information Lot 5707453
Recalling Firm/
Manufacturer
Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
For Additional Information ContactMichelle Gudith
763-494-1194
Manufacturer Reason
for Recall
Some of the recalled catheters have a component that has levels of pyrogens above specification.
FDA Determined
Cause 2
Other
ActionConsignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
Quantity in Commerce2 catheters
DistributionThe recalled products were distributed to consignees located nationwide in the United States.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LOX
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